<%BANNER%>

Record for a UF thesis. Title & abstract won't display until thesis is accessible after 2015-05-31.

DARK ITEM
Permanent Link: http://ufdc.ufl.edu/UFE0045453/00001

Material Information

Title: Record for a UF thesis. Title & abstract won't display until thesis is accessible after 2015-05-31.
Physical Description: Book
Language: english
Creator: Gonzales, Dominique L
Publisher: University of Florida
Place of Publication: Gainesville, Fla.
Publication Date: 2013

Subjects

Subjects / Keywords: Latin American Studies -- Dissertations, Academic -- UF
Genre: Latin American Studies thesis, M.A.
bibliography   ( marcgt )
theses   ( marcgt )
government publication (state, provincial, terriorial, dependent)   ( marcgt )
born-digital   ( sobekcm )
Electronic Thesis or Dissertation

Notes

Statement of Responsibility: by Dominique L Gonzales.
Thesis: Thesis (M.A.)--University of Florida, 2013.
Local: Adviser: Hernandez, Berta Esperanza.
Electronic Access: INACCESSIBLE UNTIL 2015-05-31

Record Information

Source Institution: UFRGP
Rights Management: Applicable rights reserved.
Classification: lcc - LD1780 2013
System ID: UFE0045453:00001

Permanent Link: http://ufdc.ufl.edu/UFE0045453/00001

Material Information

Title: Record for a UF thesis. Title & abstract won't display until thesis is accessible after 2015-05-31.
Physical Description: Book
Language: english
Creator: Gonzales, Dominique L
Publisher: University of Florida
Place of Publication: Gainesville, Fla.
Publication Date: 2013

Subjects

Subjects / Keywords: Latin American Studies -- Dissertations, Academic -- UF
Genre: Latin American Studies thesis, M.A.
bibliography   ( marcgt )
theses   ( marcgt )
government publication (state, provincial, terriorial, dependent)   ( marcgt )
born-digital   ( sobekcm )
Electronic Thesis or Dissertation

Notes

Statement of Responsibility: by Dominique L Gonzales.
Thesis: Thesis (M.A.)--University of Florida, 2013.
Local: Adviser: Hernandez, Berta Esperanza.
Electronic Access: INACCESSIBLE UNTIL 2015-05-31

Record Information

Source Institution: UFRGP
Rights Management: Applicable rights reserved.
Classification: lcc - LD1780 2013
System ID: UFE0045453:00001


This item has the following downloads:


Full Text

PAGE 1

1 TRADE AND HUMAN RIGHTS: USING THE RULES OF FREE TRADE TO BOLSTER PRACTICABLE ACCESS TO THE RIGHT TO HEALTH By DOMINIQUE LOCHRIDGE GONZALES THESIS PRESENTED TO THE GRADUATE SCHOOL OF THE UNIVERSITY OF FLORIDA IN PARTIAL F ULFILLMENT OF THE REQUIREMENTS FOR THE DEGREE OF MASTER OF ARTS UNIVERSITY OF FLORIDA 2013

PAGE 2

2 2013 Dominique Lochridge Gonzales

PAGE 3

3 To the most admirable, supportive, and fun group of people imaginable: My h usband, my parents, and my brother

PAGE 4

4 ACKNOWLEDGMENTS I would like to thank my parents for providing such wonderful examples of diligence and a strong work ethic, as well as being so supportive of my academic endeavors. In particular, I would like to thank my dad for reading every paper that I have written during my collegiate career with his keen eye and always providing both praise and insightful suggestions for modifications. I would like to thank the University of Florida for offering the uniquel y educational and enjoyable joint degree program of Law and Latin American Studies which I have been privileged to be a part of. I hope to put what I have learned during this program to good use for decades to come. I would also like to thank my committe e members: Professor Berta Hernndez Truyol, Dr. Terry McCoy, and Professor Stephen Powell. In particular, I would like to thank Dr. McCoy for initiating my interest in Latin American Studies and suggesting this joint degree program. Additionally, I would like to thank Professors Hernndez Truyol this thesis topic and sparked my desire for a future career in bolstering access to human rights through economic policies.

PAGE 5

5 TABLE OF CONTENTS page ACKNOWLEDGMENTS ................................ ................................ ................................ .. 4 ABSTRACT ................................ ................................ ................................ ..................... 7 CHAPTER 1 INTRODUCTION ................................ ................................ ................................ ...... 9 Outline ................................ ................................ ................................ .................... 12 Significance ................................ ................................ ................................ ............ 18 2 U.S. L ATIN AMERICAN FREE TRADE AGREEMENTS AND ACCESS TO MEDICINE ................................ ................................ ................................ .............. 19 Section 1: Right to Health ................................ ................................ ....................... 21 Section 2: TRIPS ................................ ................................ ................................ .... 30 Section 3: TRIPS plus provisions: Chilean FTA and CAFTA DR ............................ 38 TRIPS plus Provisions: Data Exclusivity ................................ .......................... 39 TRIPS plus Provisions: Prohibitions on Parallel Importation, Patent Linkages, and Patent Term Extensions ................................ ......................... 43 U.S. Jordan FTA ................................ ................................ .............................. 46 Effects of TRIPS Plus Provisions ................................ ................................ ..... 48 Panama, and Peru ................................ ................................ ............................... 54 Secti on 5: Future Changes ................................ ................................ ..................... 58 3 IMPLEMENTATION OF COMPULSORY LICENSES ................................ ............. 63 Section 1: Compulsory Licenses in Action ................................ .............................. 65 Thailand ................................ ................................ ................................ ............ 67 Ecuador ................................ ................................ ................................ ............ 70 Brazil ................................ ................................ ................................ ................ 72 Co mpulsory Licenses for Importation ................................ ............................... 75 Section 2: Constraints on Compulsory Licenses ................................ ..................... 77 Legal and Political Constraints ................................ ................................ ......... 77 Economic Constraints ................................ ................................ ...................... 79 FDI ................................ ................................ ................................ ............. 79 Shadow pricing ................................ ................................ .......................... 82 ................................ ................................ ......................... 83 Domestic manufacturing capabilities ................................ .......................... 84 Section 3: Collaborative Action ................................ ................................ ............... 86 Steps for Collaborative Procurement ................................ ................................ 87 Steps for Pooled Compulsory Licenses ................................ ............................ 87

PAGE 6

6 Fostering Conditions for Pooled Compulsory Licenses ................................ .... 89 Latin American Propensities for Pooled Compulsory Licenses ........................ 90 Section 4: Future Changes ................................ ................................ ..................... 92 4 THE RULES OF FREE TRADE AND ACCESS TO NUTRITION ........................... 94 Section 1: Fortification ................................ ................................ ............................ 98 Section 2: GATT ................................ ................................ ................................ ... 100 Section 3: SPS Agreement ................................ ................................ ................... 104 General Principles for the Addition of Essential Nutrients to Food ................. 107 Risk Assessment ................................ ................................ ............................ 114 Section 4: TBT Agreement ................................ ................................ .................... 117 5 U.S. LATIN AMERICAN FREE T RADE AGREEMENTS AND HEALTHY WORKING CONDITIONS ................................ ................................ ..................... 122 Section 1: Occupational Health Standards under ILO and WHO Conventions ..... 127 Occupati onal Safety and Health Convention ................................ .................. 128 Occupational Health Services Convention ................................ ..................... 130 WHO ................................ ................................ ................................ ............... 131 Section 2: NAFTA ................................ ................................ ................................ 133 Provisions ................................ ................................ ................................ ....... 134 Complaints brought under the Provisions of NAALC ................................ ...... 136 Effects ................................ ................................ ................................ ............ 138 Section 3: U.S. Jordan FTA ................................ ................................ .................. 139 Provisions ................................ ................................ ................................ ....... 139 Effects ................................ ................................ ................................ ............ 142 Section 4: CAFTA DR ................................ ................................ ........................... 142 Provisions ................................ ................................ ................................ ....... 142 Comp laints brought under the Provisions of CAFTA DR ................................ 147 Effects ................................ ................................ ................................ ............ 148 ................................ .................. 149 Provisions ................................ ................................ ................................ ....... 149 Effects ................................ ................................ ................................ ............ 153 Section 6: Future FTAs ................................ ................................ ......................... 154 Proposed Substantive Provisions ................................ ................................ ... 154 Proposed Dispute Resolution Mechanisms ................................ .................... 156 Rewarding Positive Steps ................................ ................................ ............... 157 Additional Steps to Boost Access to Healthy Working Conditions .................. 159 Conclusion ................................ ................................ ................................ ...... 160 6 CONCLUSION ................................ ................................ ................................ ...... 162 REFERENCE LIST ................................ ................................ ................................ ...... 164 BIOGRAPHICAL SKETCH ................................ ................................ .......................... 180

PAGE 7

7 Abstract of Thesis Presented to th e Graduate School of the University of Florida in Partial Fulfillment of the Requirements for the Degree of Master of Arts TRADE AND HUMAN RIGHTS: USING THE RULES OF FREE TRADE TO BOLSTER PRACTICABLE ACCESS TO THE RIGHT TO HEALTH By Do minique Lochridge Gonzales May 2013 Chair: Berta Hernndez Truyol Major: Latin American Studies Th e right to health, defined highest attainable standar not only includes states taking steps to progressively realize the treatment and prevention of diseases but also applies to the conditions which support a healthy life such as nutrition and healthy working conditions. The rules of international trade, such as World Trade Or ganization treaties and free trade agreements ( FTAs), provide avenues for states to more effectively respect, protect, and fulfill the right to health, and this thesis examines four different areas through which Latin American states can wield the tools pr ovided in the se rules. Chapters 2 and 5 examine the varying impacts on access to medicine and healthy working conditions of different FTAs between the U.S. and Latin American states. FTAs provide an avenue for more positive human rights impacts than TRIPS FTAs, and Chapter 5 provides a framework for provisions of future FTAs to better foster healthy working conditions. Chapter 3 focuses on how to better encourage utilization of these

PAGE 8

8 avenues under the rules of trade positing that developing the necessary preconditions for pooled compulsory licenses to import pharmaceutical products offer s the most promising strategy. Chapter 4 addresses approache s fo r promoting food fortificati on and puts forth the argument that measures which are i mplemented to promote fortified foods even though they may limit international trade do not necessarily violate the relevant trade rules.

PAGE 9

9 CHAPTER 1 INTRODUCTION The human right to health has II and which encompass multiple dimensions of requisite security for human rights. These freedoms include the freedom from fear (security fr om aggression); the freedom of speech and expression (political security); the freedom of conscience (intellectual and religious security), and freedom from want (economic security). 1 Access to adequate healthcare is a crucial component of freedom from wan t; moreover, a population that lacks sufficient healthcare is not one that can truly access and execute its freedoms of conscience, speech, and expression. The Four Freedoms were also a source for the values and purposes of the UN Charter, which forms the foundation of the international legal system and include s the dignity and worth of each human person and the active promotion of the conditions underlying the socioeconomic development of all peoples. 2 Furthermore, Article 55 of the UN Charter dictates tha t the states of the United Nations social progress and development. 3 In order to define the fundamental human rights referred to in the preamble of the UN Charter, the UN Human Rights Commission, led by Eleanor Roosevelt, began 1 Winston P. Nagan, Human Right s, Liberty & Socio Economic Justice: Economic Theory and the Ascent of Private Property Values 1 C ADMUS 1, 2 n.2 (2011). 2 Id. at 3; U.N. Charter preamble. 3 U.N. Charter, supra note 2, at art. 55.

PAGE 10

10 drafting the Universal Declaration of Human Rights (UDHR) in 1946. 4 The UDHR 5 These ght to a standard of living adequate for the health and well being of himself and of his family, including food, clothing, housing, medical care and 6 Further delineating the right to health, Article 12(1) of the International Co venant on Economic, Social, and Cultural Rights (ICESCR) notes that state parties to that 7 To ensure that their populations have access to this right, state parties will take prevention, treatment and control of epidemic, endemic, occupational and other diseases [and] [t]he creation of conditions which would assure to all medica l service 8 The Committee on Economic, Social, and Cultural Rights (the body of experts which monitors the implementation of the ICESCR by state parties and interprets its provisions in General Comments) int erprets the right to health in Article 12 as not merely a right to timely and adequate healthcare but also to the conditions which 4 Peter Bailey, The Creation of the Declaration of Human Rights U NIVERSAL H UMAN R IGHTS N ETWORK http://www.universalrights.net/main/creation.htm (last visited Sep. 23, 2011). 5 The Universal Declaration of Human Rights art. 1, G.A. Res. 217, U.N. GAOR, 3d Sess., U.N. Doc. A/810 (1948) [ hereinafter UDHR]. 6 Id. at arts. 3, 25(1). 7 International Covenant for Economic, Social, and Cultural Rights art. 12(1), Dec. 16, 1966, 993 U.N.T.S. 3 [ hereinafter ICESCR]. 8 Id. at art. 12(2)(c d).

PAGE 11

11 support a healthy life such as nutrition, potable water, adequate sanitation, and healthy working and environmental condition s. 9 Additionally, taking into consideration budgetary constraints, state parties must offer physically and economically accessible health facilities, goods, and services of sufficient quality (meeting the appropriate medical or scientific approvals). 10 Giv and trade policies will clearly have a substantial impact on its strategies (and the effectiveness of those strategies) to respect, protect, and fulfill the right to health. The rules of international trade, such as the international intellectual property law delineated in the Agreement on Trade Related Aspects of Intellectual Property Rights ( TRIPS ), 11 the Sanitary and Phytosanitary Measures Agreement (SPS Agreement), 12 the Agreem ent on Technical Barriers to Trade (TBT Agreement), 13 and free trade agreements (FTAs) which states enter into, offer avenues for more effectively implementing the right to health. This thesis examines four different areas through 9 U.N. Econ. & Soc. Council, Comm. on Econ., Soc. and Cultural Rights, Gene ral Comment No. 14(11): The Right to the Highest Attainable Standard of Health, U.N. Doc. E/C. 12/2000/4 (Aug. 11, 2000) [ hereinafter ICESCR General Comment 14]. 10 Id. at ICESCR General Comment 14(12). 11 Agreement on Trade Related Aspects of Intellectual Property Rights, Apr. 15, 1994, 33 I.L.M. 81 [ hereinafter TRIPS]. 12 Agreement on the Application of Sanitary and Phytosanitary Measures, GATT Doc. MTN/FA II A1A 4 (Dec. 15, 1993) (entered into force January 1, 1995), available at http://www.wto.org/englis h/tratop_e/sps_e/spsagr_e.htm#fnt5 [ hereinafter SPS Agreement]. 13 Agreement on Technical Barriers to Trade, Apr. 15, 1994, Marrakesh Agreement Establishing the World Trade Organization, Annex 1A, Legal Instruments -Results of the Uruguay Round,1868 U.NT.S 120 (entered into force January 1, 1995), available at http:// www.wto.org/english/docs_e/legal_e/17 tbt_e. htm [ hereinafter TBT Agreement].

PAGE 12

12 which Latin American state s can wield the tools provided in the rules of trade to more effectively respect, protect, and fulfill the right to health. Outline First, in Chapter 2: U.S. Latin American Free Trade Agreements and Access to Medicine, analyzes the effects of FTA provision s on access to medicine. Access to medicine lies at the heart of the crossroads between the international human right to health and international intellectual property law delineated in TRIPS True availability of essential medicines to millions of people depends on a balance between the formations of these medicines in the first place (through rewarding innovation) and promulgating rules that allow for practicable access to those medicines. FTAs provide a method for implementing the right to health by fost ering practicable access to essential medicines in the TRIPS framework. However, ensuing from the differing provisions in these FTAs s to this right. Chapter 2 examines the impacts on access to medicine of two groups of FTAs TRIPS provisions and FTAs in accordance with the New Trade Policy. The provisions of the for mer, which include the U.S Chile FTA, the Dominican Republic Central America U.S. FTA (CAFTA DR), and Trans Pacific Partnership (TPP) (still in negotiations), limit state TRIPS or surpass the requirement s of TRIPS However, the FTAs between the U.S. and Colombia, Peru, and Panama

PAGE 13

13 by President Bush and Congress on May 10, 2007. 14 TRIPS 15 TRIPS DR, and the TPP. Chapter 3: Implementation of Compulsory Licenses focuses on a corollary concern: how to encourage Latin American states (particularly the Central American states with relatively smaller populations) to utilize these flexibilities under TRIPS such as the ability to issue compulsory licenses (licenses granted to a producer to produce a low and middle income Latin American states to issue compulsory licenses may be a key tactic in achieving affordable access to many types of medicines since nearly all pharmaceutical companies price their products at the same price worldwide. 16 By not employing a price discrimination strategy based on per capita GDP for a particular pharmaceutical product, a deadweight loss often occurs since many consumers who would buy that product cannot afford to do so. 17 This deadweight loss could be 14 Charles B. Rangel, Moving Forward: A New Bipartisan Trade Policy that Reflects American Values 45 H ARV J. ON L EGIS 377, 377 78 (2008); USTR to push for 12 years of Data Exclusivity for Biologics in TPPA I NSIDE U.S. T RADE (May 30, 2011), http://donttradeourlivesaway.wordpress.com/2011/05/30/ustr to push for 12 years of data exclusivity for biologics in tppa/. 15 Rangel, supra note 14, at 401. 16 Jerome H. Reichman, Compulsory licensing of patented pharmaceutical inventions: evaluating the options 37 J. L AW M ED & E THICS 247, 251 n.2 (2009). 17 Id. at 251.

PAGE 14

14 decreased through selling that product to large numbers of persons in low or middle income states at lower prices (but still above the marginal cost of production). 18 unavailable to scores of person s around the world, the number of states that have executed compulsory licenses has been relatively small, and Brazil and Ecuador are the only Latin American states to have done so for pharmaceutical products 19 Therefore, an analysis of the instances in wh ich other states have implemented compulsory licenses and the legal, economic, and political constraints on issuing these licenses is essential to ascertaining the requisite steps that Latin American states must take in order to put themselves in the posit ion of being able to feasibly issue and carry out compulsory licenses. Chapter 3 examines instances in which compulsory licenses were executed, as well as factors inhibiting compulsory licensing from being utilized to its fullest potential (such as a misun derstanding of TRIPS national legislation, fears of negative political consequences from other states, concerns of diminished foreign direct investment (FDI), and limited domestic manufacturing capabilities). As a more feasible strategy for implementation Chapter 3 reasons that smaller Latin American states, when circumstances legitimately warrant, issue compulsory licenses collaboratively for a certain pharmaceutical product and use the waiver to TRIPS Article 31(f) provided for in 18 Id. 19 Reed Beall & Randall Kuhn, Trends in Compulsory Li censing of Pharmaceuticals Since the Doha Declaration: A Database Analysis, 9 PL O S 1, 4 n.1 (2012).

PAGE 15

15 the Decision on the In terpretation of Paragraph 6 (Paragraph 6 Decision) 20 to import that product from another WTO member state which has the capability to manufacture it. Pooled compulsory licenses to import pharmaceutical products offer the most promising strategy for smaller Latin American states to execute compulsory licenses, and Chapter 3 concludes by describing steps that Latin American states and possible exporter states should take to create the necessary conditions for such licenses. Beyond access to medicine, the right 21 which constitutes the focus of Chapter 4: The Rules of Free Trade and Access to Nutrition. To achieve full realization of the right to health, ICESCR state parties are bound to take specific and continuous 22 nutritionally deficient. 23 Children and pregnant women are th e most susceptible to these deficiencies (in Latin America, nine million children (under the age of five) are malnourished) 24 and even if a person merely suffers from a moderate deficiency, there will still likely be serious, long 20 Implementation of Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health, Decision of 30 August 2002, Doc. WT/L/540 (entered into force Sep. 2, 2003) [ hereinafter Paragraph 6 Decision]. 21 Id. 22 ICESCR General Comment 14, supra note 9, at 14(15, 36). 23 L INDSAY A LLAN B RUNO DE B ENOIST O MAR D ARY & R ICHARD H URRELL (eds.), G UIDELINES ON F OOD F ORTIFICATION WITH M ICRONUTRIENTS : WHO AND F OOD AND A GRICULTURAL O RGANIZATION OF THE U NITED N ATIONS 3 (2006), available at http://www.who.int/nutrition/publications/guide_food_fortification_micronutrients.pdf. 24 Malnutrition costs Latin America billions of dollars per year A LERT N ET (Oct. 15, 2009), http://www.trust.org/alertnet/news/malnutrition costs latin america billions of dollars per year/.

PAGE 16

16 term consequences on his or her physical health and mental development. 25 These outcomes will also have a significant impact at the macro level through the loss of human capital formation, economic productivity, and rising public health costs since micronutrient deficiencies accoun t for 7.3% of global disease incidence. 26 Guatemala, where nearly half of children suffer from chronic malnutrition, U.N. estimates put the cost at $3.1 billion (U.S. dollars (USD)) a year in 2004, or 11 percent 27 One of the cost efficient means for achieving the realization of and access to a more essential nutrients to a food whether or not it is normally contained in the food for the purpose of p reventing or correcting a demonstrated deficiency of one or more 28 This Chapter puts forth the argument that measures which are implemented to promote fortified foods but in doing so, may limit i nternational trade fall under the purview of and do not necessarily violate the relevant trade rules found in the SPS Agreement which covers food safety regulations. However, if it is determined that measures to promote fortified foods do not fall under the purview of the SPS Agreement, then they would be subject to the TBT Agreement and, like with the SPS Agreement, could be properly tailored in order to comply with the TBT Agreement. 25 Id. 26 Id. 27 Id. 28 Codex General Principles for the Addition of Essential Nutrients to Food 2.5, CAC/GL 09 1987 (amended 1989, 1991).

PAGE 17

17 titute another fundamental determinant of health, 29 and the manners through which different subject of Chapter 5: U.S. Latin American Free Trade Agreements and Healthy Workin g parties to take in order to achieve full realization of the right to healt h. 30 The ICESCR occupational accidents and diseases. the prevention and reduction of the populati on's exposure to harmful substances [and] detrimental environmental conditions that directly or indirectly impact upon human health the minimization, so far as is reasonably practicable, of the causes of health hazards inherent in the working e 31 Like access to medicine, FTAs such as NAFTA, the U.S Jordan FTA, CAFTA Panama, and Peru) promote occupational he alth in varying ways, and Chapter 5 evaluates the substantive and procedural provisions of these FTAs according to the provisions on the capacity of a state to meet its responsibil ities to progressively realize 29 ICESCR General Comment 14, supra note 9, at 14(4). 30 ICESCR, supra note 7, at art. 12(2)(c). 31 ICESCR General Comment 14, supra note 9, at 14(15).

PAGE 18

18 this component of the right to health and on the capacity of individuals and groups to have practicable access to this area o f the right to health. A n analysis of the im pacts of these FTAs will indicate that while their poten tials for positive impacts on human rights have expanded, look like and Chapter 5 concludes by offering a fr amework for provisions of future FTAs Significance strategies in the profitabl e area of free trade for achieving practicable positive effects on access to the human right to health. Chapters 2 and 5 provide comparative human rights impact assessments of the terms of various FTAs on access to medicine and occupational health which we re not found directly in any other sources. Chapter 3 examines the reasons why smaller Latin American states specifically have not executed licenses could be effectively impl emented by these particular states, which was not found in any other sources. Lastly, Chapter 4 develops the argument that measures to promote fortified foods may restrict trade but do not necessarily violate the SPS Agreement or TBT Agreement and thus co uld be effectively used in Latin America. No examples were found of this argument applied specifically to Latin America. Moreover, only in a handful of other papers were a few sentences or a paragraphs found addressing whether these agreements either would or would not be violated by such measures, but Chapter 4 will offer a more complete argument on those issues.

PAGE 19

19 CHAPTER 2 U.S. LATIN AMERICAN FREE TRADE AGREEMENTS AND ACCESS TO MEDICINE The values which underlie the international legal system and are li sted in the UN Charter include the dignity and worth of each human person, the equal rights of all persons regardless of sex or nationality, and the active promotion of the conditions underlying the socioeconomic development of all peoples. 1 The human righ ts stemming from these values were delineated in subsequent documents; one of these rights is the right for everyone to share and enjoy the fruits of scientific development. 2 One of the areas of great scientific advancement over the last century has been i n the area of essential medicines. However, all are not benefiting from this scientific progress; millions of deaths in developing states each year are the consequences of diseases for which there are treatments 3 Over 17.5 million people perish annually a s a result of communicable illnesses and maternal/neonatal conditions in low and middle income states. 4 Furthermore, only eight medical conditions/diseases account for 29 percent of deaths in low and middle s, vaccine preventable diseases of childhood, malaria, respiratory infections, maternal conditions, 5 According to UN Special Rapporteur on the Right to Health Paul edicines could 1 U.N. Charter preamble. 2 The Universal Declaration of Human Rights art. 27( 1 ) G.A. Res. 217, U.N. GAOR, 3d Sess., U.N. D oc. A/810 (1948) [ hereinafter UDHR] ; International Covenant for Economic, Social, and Cultural Rights art. 1 5 (1) (b) Dec. 16, 1966, 993 U.N.T.S. 3 [ hereinafter ICESCR]. 3 Graham Dutfield, Delivering Drugs to the Poor: Will the TRIPS Amendment Help? 34 A M J.L. & M ED 107, 108 (2008). 4 Id. 5 Id.

PAGE 20

20 save 10 million lives each year. Access to medicines is characterized by profound 6 Access to medicine lies at the hear t of the crossroads between two areas of international law: the international human right to health and international intellectual property law delineated in TRIPS True availability of essential medicines to millions of people depends on a balance between the formations of these medicines in the first place (through rewarding innovation) and promulgating rules that allow for practicable access to those medicines. FTAs offer an avenue for implementing the right to health by fostering practicable access to e ssential medicines in the TRIPS framework. However, ensuing from the differing provisions in these FTAs are varying consequences on access to medicine. The analysis of these consequences will be based on the UN Office of the High Commissioner for Human Rig impact of trade agreements on human rights. 7 This framework sets human rights norms agreements and structures the analysis in terms of measuring the impact of the provisions of these trade agreements on the capacity of the state to meet its responsibilities under the applicable customary international legal norms and treaties (in this case related to the right to health and acces s to medicine), as well as measuring 6 Charles B. Rangel, Moving Forward: A New Bipartisan Trade Policy that Reflects American Values 45 H ARV J. ON L EGIS 377, 400 (2008); USTR to push for 12 years of Data Exclusivity for Biologics in TPPA I NSIDE U .S. T RADE (May 30, 2011), http://donttradeourlivesaway.wordpress.com/2011/05/30/ustr to push for 12 years of data exclusivity for biologics in tppa/. 7 Simon Walker, The United States Dominican Republic Central American Free Trade Agreement and Access to M edicines in Costa Rica: A Human Rights Impact Assessment 3 J H UM R TS P RAC 188, 188 n.2 (2011).

PAGE 21

21 the impact of the provisions on the capacity of individuals and groups to have practicable access to the right to health (through available and affordable medications of sufficient quality), as delineated in internation al law and national legislation. 8 Section 1 examines the international legal underpinnings of the right to health; Section 2 analyzes the applicable TRIPS provisions regarding access to medicine. Sections 3 and 4 examine the differing provisions regarding access to medicines in access to this right. Section 5 discuss es future change s to bolster the human rights impacts of FTAs. Section 1: Right to Health As previously noted, the roots of the express right to health are found in dimensions of requisite security for human rights and include freedom from want (economic security). 9 Access to adequate healthcare is a crucial component of freedom from want; moreover, a population that lacks sufficient healthcare is not one that can truly access and execute its freedo ms of conscience, speech, and expression. President Roosevelt was clearly cognizant to the significance of the right to health; he approved a Bill of Socio economic Rights to send to Congress which encompassed the right to adequate medical care. 10 8 Id. at 193. 9 Winston P. Nagan, Human Rights, Liberty & Socio Economic Justice: Economic Theory and the Ascent of Private Property Values 1 C ADMUS 1, 2 n. 2 (2011). 10 Id. at 4.

PAGE 22

22 The Four Freedoms were also a source for the values and purposes of the UN 11 Furthermore, Article 55 of the UN standards of living [and] conditions of economic and social progress and 12 Both of these necessarily encompass a right to health, and further evidence is found in Articles 13 and 55 which call for both the UN General Assembly and the United Nations as a whol e to foster international collaboration in the health field. 13 The Vienna Convention on the Law of Treaties delineates that state parties to a treaty, such as the UN Charter, are bound to that treaty and must execute the provisions of that treaty in good fa ith; 14 additionally, state parties may not use provisions of domestic law to justify failing to execute the provisions of a treaty which it has ratified. 15 To further define the fundamental human rights referred to in the UN Charter, the UN Human Rights Comm ission, led by Eleanor Roosevelt, began drafting the Universal 1946. 16 11 Id. at 3; U.N. Charter, supra note 1 at preamble. 12 U.N. Charter, supra note 1 at art. 55. 13 Id. at arts. 13(1)(b), 55(b). 14 Vienna Convention on the Law of Treaties art. 26, May 23, 1969, 1155 U.N.T.S. 331. 15 Id. at art. 27. 16 P eter Bailey, The Creation of the Declaration of Human Rights U NIVERSAL H UMAN R IGHTS N ETWORK http://www.universalrights.net/main/creation.htm (last visited Sep. 23, 2011).

PAGE 23

23 17 The the health and well being of himself and of his family, including food, clothing, housing, 18 On December 10, 1948, the UN General Assembl y endorsed the UDHR without any dissenting votes. 19 While UN General Assembly Resolutions and Declarations are not binding international law (as a treaty or UN Security Council decision is), the UDHR is binding international law in the form of customary in ternational law 20 (a type of international law denoted by consistent state practice and opinio juris do so)) 21 As customary international law, the UDHR is binding upon all states which did not repudiate it during its f ormation; as no state dissented from endorsing the UDHR, its provisions are binding on all states 22 with the International Covenant on Civil and Political Rights (ICCPR) and the International Covenant on Eco nomic, Social, and Cultural Rights (ICESCR) which 23 As treaties, these covenants are binding upon the state parties which have ratified them. However, the ICESCR is so widely rat ified, adhered to, and enforced that it arguably constitutes customary international law, which is binding upon states, such as the U.S., 17 UDHR, supra note 2 at art. 1. 18 Id. at arts. 3, 25(1). 19 Bailey, supra note 1 6. 20 Id. 21 Eleanor D. Kinney, The International Human Right to Health: What Does This Mean for our Nation and World 34 I ND L. R EV 1457, 14 64 (2001). 22 Id. 23 Id.

PAGE 24

24 which have not ratified the ICESCR. 24 Moreover, in the U.S., customary international 25 Covenant recognize the right of everyone to the enjoyment of the highest attainable 26 To ensure that their populations have access to this r prevention, treatment and control of epidemic, endemic, occupational and other diseases [and] [t]he creation of conditions which would assure to all medical service and me 27 The Committee on Economic, Social, and Cultural Rights (the body of experts which monitors the implementation of the ICESCR by state parties and interprets its provisions in General Comments) 28 interprets the righ t to health in Article 12 as not merely a right to timely and adequate healthcare but also to the conditions which support a healthy life such as nutrition, potable water, adequate sanitation, and healthy working and environmental conditions. 29 The Committe e also noted that since the 24 Rhonda Copelon, The Indivisible Framework of International Human Rights: A Source of Soc ial Justice in the U.S. 3 N.Y. C ITY L. R EV 59 64 (1998); Kinney, supra note 21 at 14 64 25 Tina S. Bhatt, Amending TRIPS: A New Hope for Increased Access to Essential Medicines 33 B ROOK J. I NT L L. 597, 621 (2008). 26 ICESCR, supra note 2 at art. 12( 1). 27 Id. at art. 12(2)(c d). 28 Committee on Economic, Social and Cultural Rights O FFICE OF THE U NITED N ATIONS H IGH C OMMISSIONER FOR H UMAN R IGHTS http://www2.ohchr.org/english/bodies/cescr/index.htm (last visited Jan 1, 2013). 29 U.N. Econ. & Soc. Counci l, Comm. on Econ., Soc. and Cultural Rights, General Comment No. 14(11): The Right to the Highest Attainable Standard of Health, U.N. Doc. E/C. 12/2000/4 (Aug. 11, 2000) [ hereinafter ICESCR General Comment 14].

PAGE 25

25 enjoyment of a variety of facilities, goods, service s and conditions necessary for the 30 Taking into account budgetary constraints, state parties must offer physically and economically accessible health facilities, goods, and services of sufficient q uality (meeting the appropriate medical or scientific approvals). 31 Additionally, those essential medicines listed in the World Health 32 must be available 33 The Committee on Eco nomic, Social, and Cultural Rights explained that the right to prevention and treatment of diseases in ICESCR Article 12(2)(c) encompasses a system of medical care to address accidents, epidemics, and emergencies; control of ividual and joint efforts to make available relevant technologies the implementation or enhancement of immunization programmes and 34 The establishment of conditions which would allow for medical s ervices and attention in the case of an illness (in Article health services and health education; regular screening programmes; appropriate 30 Id. at ICESCR General Comment 14(9). 31 Id at ICESCR General Comment 14(12). 32 WHO Model Lists of Essential Medicines WHO, March 2011, http://www.who.int/medicines/publications/essentialmedicines/en. 33 ICESCR General Comment 14, supra note 2 9, at 14(12)(a). 34 Id. at ICESCR General Comment 14(16 ).

PAGE 26

26 treatment of prevalent dise ases, illnesses, injuries and disabilities, preferably at the community level; the provision of essential drugs; and appropriate mental health 35 In addition to respecting the right to health by not hampering access to healthcare/medicin es and protecting this right through ensuring that other parties will not restrict this access, state parties are bound to proactively fulfill the right to health by making specific and continuous steps towards its realization, such as legislation of a na tional health policy (delineating tactics and resources for realizing the right to health), funding towards a public health infrastructure, training medical personnel, fostering the establishment of healthcare facilities, and informational campaigns. 36 Sign ificantly, a state party which does not use the maximum of its available resources to fully execute the right to health is in violation of the ICESCR. 37 Among the core obligations of state parties is to provide access to the essential medicines in the WHO M odel Lists for Essential Medicines for Adults and Children. 38 Access to immunizations is also of high priority 39 progressive realization of this right 40 Of particular significance to the topic of this paper, state parties are called to give due consideration to the right to health in international 35 Id. at ICESCR General Comment 14(17). 36 Id. at ICESCR General Comment 14(36). 37 Id. at ICESCR General Comment 14(47). 38 Id. at ICESCR General Comment 14(43)(d). 39 Id. at ICESCR General Comment 14(44)(b). 40 Kathryn Bromley, From Legal Universalism to L egal Pluralism: Expanding and Enhancing the Human Rights Approach to HIV/AIDS 21 S. A FR J. ON H UM R TS 191, 195 (2005).

PAGE 27

27 41 However, regarding enforcement, the to periodically report their steps to progressively implement the rights under the ICESCR to the Committee on Economic, Cultural, and Social Rights. 42 Additionally, there has been scant assessment by the Committee or any other body to more fully assess implementation. 43 Even more crucially, there is no t currently a tribunal (like exists under the ICCPR) for citizens of ICESCR state parties to bring claims of violations of their rights. 44 While the right to health has been reaffirmed in other international legal documents, such as in Article 10 of the Additional Protocol to the American Convention 45 there is not yet hom ogeneous agreement regarding the customary legal status of this right 46 A s previously noted, customary international law legally binds 41 ICESCR General Comment 14, supra note 2 9, at 14(39). 42 Emily M. Cowley, der the Central American Free Trade Agreement and the International Covenant on Economic, Social, and Cultural Rights 11 M ICH S T U. J. M ED & L. 227, 232 (2007). 43 Id. 44 Id. However, the Optional Protocol to the ICESCR, which establishes processes for i ndividuals to submit complaints of alleged ICESCR violations to the ICESCR Committee (which may also instigate investigations regarding alleged ICESCR violations), was adopted by the UN General Assembly in 2008. As of February 7, 2013, ten state parties ha ve ratified the Protocol (including Argentina, Bolivia, Ecuador, El Salvador, and Uruguay), and therefore, the Protocol will go into effect on May 5, 2013. Optional Protocol to the ICESCR, U NITED N ATIONS T REATY C OLLECTION (Feb. 2, 2013), http://treaties.un .org/Pages/ViewDetails.aspx?src=TREATY&mtdsg_no=IV 3 a&chapter=4&lang=en.. 45 Additional Protocol to the American Convention on Human Rights in the area of Economic, Social, and Cultural Rights: Protocol of San Salvador art. 10, Nov. 14, 1988, 28 I.L.M. 16 1 [ hereinafter Protocol of San Salvador]. 46 Bhatt, supra note 25, at 608.

PAGE 28

28 states regardless of treaty ratification and in the context of the right to health would bind the U.S. which is not an IC ESCR signatory 47 T he U.S. Court of Appeals, Second Circuit, held in Flores v. Southern Peru Copper Corporation 48 that the right to health is 49 50 customary international legal norm. Contrarily, evide nce of its customary legal character includes the wide acceptance of non binding legal instruments addressing with the right to health (such as the Vienna Declaration and Programme of Action and UN Commission on Human Rights resolutions); wide spread ratif ication of multilateral treaties that establish the right to health (there are currently 160 state parties to the ICESCR); 51 inclusion of the right to health in many national constitutions; and the justiciable nature of the right to health before many nati onal judiciaries. 52 For instance, in Paschim banga Khet Samity v. State of West Bengal 53 a case before the Supreme Court of India in 1996, the petitioner was hit by a train and then denied treatment at six successive state hospitals because the 47 of appropriate jurisdiction as often as questions of right depending upon i t are duly presented for their determination. For this purpose, where there is no treaty and no controlling executive or legislative act or The Paquete Habana 175 U.S. 677, 700 (1900) (emphasis added). 48 Flores v. Southern Peru Copper Corporation 414 F.3d 233 (2d Cir. 2003). 49 Id. at 254. 50 Id. ( quoting Filartiga v. Pena Irala 630 F.2d 876, 884 (2d Cir. 1980). 51 ICESCR, U NITED N ATIONS T REATY C OLLECTION (Feb. 28, 201 2), http://treaties.un.org/Pages/ViewDetails.aspx?src=TREATY&mtdsg_no=IV 3&chapter=4&lang=en. 52 See A NDREW C LAPHAM & M ARIANO G ARCIA R UBIO T HE O BLIGATIONS OF S TATES WITH R EGARD TO N ON S TATE A CTORS IN THE C ONTEXT OF THE R IGHT TO H EALTH : H EALTH AND H UMAN R IG HTS W ORKING P APER S ERIES N O 3 22 (2002)), http://www.who.int/hhr/Series_3%20Non State_Actors_Clapham_Rubio.pdf. 53 Paschim banga Khet Samity v. State of West Bengal Supreme Court of India Case No. 169, 4 SCC 37 (1996).

PAGE 29

29 hospitals ei ther had inadequate medical facilities or lacked any vacant beds. 54 The Court declared that the right to life enshrined in the Article 21 of the Indian Constitution imposes an obligation on the state to safeguard the right to life of every person and that t he denial of timely medical treatment necessary to preserve human life in government owned hospitals is a violation of this right. 55 The Court ordered the West Bengali state governm ent to pay compensation to the petitioner as well as enact remedial measures to ensure that proper medical faciliti es were available in the future. 56 For a second example, Mi nister of Health v. Treatment Action Campaign 57 a case before the Constitutional Court of South Africa in 2002 addressed whether the s tate had violated Secti ons 27(1(a), [e] veryone has the right to have access to health care services the state must take reasonable legislative and other measures, within its available resources, to achieve the progressive reali[z]atio r ough only permitting Nevirapine (a drug that reduces mother to child HIV transmission) to be available at select pilot sites (instead of all public hospitals and clinics) after the manufacturer offered to provide it at no cos t for five year s 58 he question in the present case, therefore, is not whether socio economic rights are justiciable. Clearly they are. The question is whether the applicants have shown that measures adopted by the 54 Id. at 2. 55 Id. at 9. 56 Id. at 9, 10. 57 Minister of Health v. Treatment Action Campaign Constitutional Court of South Africa, CCT 8/02 (2002). 58 Id. at 2.

PAGE 30

30 government to provide access to health care services for HIV positive mothers and their 59 The Court found that the policy excluded a considerable societal segment, failed to distinguish between the evaluation of programs and the need to provide access to services to those lacking access, and therefore was unreasonable. 60 Rejecting the argument that granting injunctive relief would violate separation of powers, the Court ordered the government to remov e the restrictions that barred Nevirapine from being made available at public hospitals and clinics which were non research or training sites 61 In light of the current lack of an enforcement mechanism through a treaty or through all national judiciaries as customary international law, trade agreements offer a promising avenue for truly implementing the components of the right to health. Through designing trade agreements to augment the capacities of states to execute the components of the right to health an d to support practicable access of individuals and groups to the components of the right to health, trade agreements may lead to a positive impact on the human rights of millions of people. Additionally, increased state practice may strengthen a belief in obligation to implement the right to health and therefore strengthen the case for a customary legal norm of the right to health. Section 2: TRIPS Intellectual property law was developed in the form of patents for the purpose of encouraging inv ention with the objective of achieving the most extensive availability of 59 Id. at 25. 60 Id. at 67, 68. 61 Id. at 112, 135.

PAGE 31

31 new and useful goods for society. 62 Pre TRIPS the development of intellectual property rights (IPR) largely occurred within the World Intellectual Property Organization (WIPO) which administered numerous treaties such as the 1883 Paris Convention for the Protection of Industrial Property 63 and the 1886 Berne Convention for the Protection of Literary and Artistic Works 64 65 However, WIPO lacked the legal authority and capacity to monitor and secure compliance by state parties with substantive treaty obligations, 66 and IPR protection was irregularly recognized across state lines 67 The purpose of the TRIPS agreement, which entered into effect in January 1995 (in conjunction with the establis hment of the WTO) and encompassed substantive provisions of WIPO treaties 68 was to advance international trade through implementing a treaty addressing IPR which encompassed mechanisms for enforceability of treaty provisions 69 Regarding patents, TRIPS exten products or processes, in all fields of technology, provided that they are new, involve an 62 Dutfield, supra note 3 at 108. 63 Paris Convention for the Protectio n of Industrial Property, as last revised at the Stockholm Revision Conference, July 14, 1967, 828 U.N.T.S. 303 [ hereinafter Paris Convention]. 64 Berne Convention for the Protection of Literary and Artistic Works, as revised at Paris on July 24, 1971 and amended on September 28, 1979, 828 U.N.T.S. 221. 65 Ruth L. Okediji, WIPO WTO Relations and the Future of Global Intellectual Property Norms 5 (2009) ( Minnesota Legal Studies Research Paper No. 09 07 ), available at http://papers.ssrn.com/sol3/papers.cfm ?abstract_id=1338902. 66 Id. at 6. 67 Vanessa Bradford Kerry and Kelley Lee, TRIPS, the Doha declaration and Paragraph 6 Decision: what are the remaining steps for protecting access to medicines? 3 G LOBAL H EALTH 1, 2 n.3 (2007). 68 W ORLD H EALTH O RGANIZATION AND W ORLD T RADE O RGANIZATION WTO A GREEMENTS & P UBLIC H EALTH 39 (2002), available at http://www.wto.org/english/res_e/booksp_e/who_wto_e.pdf. 69 Kerry, supra note 67, at 2.

PAGE 32

32 70 This encompasses the obligation of all W TO members to make patents available for pharmaceutical innovations. 71 In addition to granting patent rights for a period of twenty years from the date of the filing of the patent application, TRIPS demarcates procedures and remedies for patent holders to e nforce their rights. 72 Article 30 of TRIPS allows for WTO members to offer limited exceptions to patent exploitation of the patent and do not unreasonably prejudice the legitima te interests of 73 For example, a WTO panel determined that Article 30 permits WTO members to establish a regulatory review exception, thus allowing activities relating to a drug patent that would typically infringe upon it so long as the sole objective of these activities is to obtain marketing approval from regulators in order to commence such marketing after the patent expires. 74 Article 31 of TRIPS authorizes all WTO members t o grant compulsory patent licenses (licenses granted to a producer to produce a patented product without the 75 Before granting a compulsory patent license, the state must 70 Agreement on Trade Related Aspects of Intellectual Property Rights, art. 27(1), Ap r. 15, 1994, 33 I.L.M. 81 [ hereinafter TRIPS]. 71 Kerry, supra note 67, at 2. 72 Id. 73 TRIPS, supra note 70, at art. 30. 74 Dutfield, supra note 3 at 110. 75 TRIPS, supra note 70, at art. 31.

PAGE 33

33 older on reasonable commercial terms and conditions and that such efforts have not been successful within 76 However, this requirement is waived under 77 In such cases, the patent holder must still be notified as soon as reasonably practicable, and in any case, the patent holder must be adequately compensated. 78 domestic ma exclusive, non assignable, and limited in their scope and duration by the purpose out of which the license arose. 79 Therefore, a WTO member state (or third party authorized by the government) may issue a compulsory license for a pharmaceutical patent to address a problem stemming from pricing or availability; however, a problem arises regarding states which lack adequate domestic manufacturing capacity to produce the pharmaceutical. 80 To address this and other possible hindrances caused by TRIPS to public health, the TRIPS Agreement and Public Health (Doha Declaration) on November 14, 2001. 81 The Ministerial Conference affirmed that TRIPS should be construed and executed in light of the ri ght to foster 76 Id. at art. 31(b). 77 Id. 78 Id. at art. 31(h). 79 Id. at art. 31(c f ). 80 Frederick M. Abbott, The WTO Medicines Decision: World Pharmaceutical Trade and the Protection of Public Health 99 A M J. I NT L L. 317, 319 20 (2005). 81 Id. at 317.

PAGE 34

34 public health and access to medicine. 82 Furthermore, the Doha Declaration highlighted that each WTO Member has the right to grant compulsory licenses, to ascertain what grounds these licenses shall be granted on, and to determine what comprise s a national emergency (though the Doha Declaration expressly notes that crises stemming from HIV/AIDS, malaria, tuberculosis, and other epidemics can create a national emergency). 83 Moreover, this Declaration called upon the Council for TRIPS to address th e problem of WTO Members which lack adequate manufacturing capacity being unable to effectively use compulsory licensing. 84 In August 2003, the Council for TRIPS responded with the Paragraph 6 Decision, final patent obstacle to cheap drug imports 85 The Paragraph 6 Decision delineates the procedures for a waiver to TRIPS im port those products from another WTO Member State under compulsory licensing. 86 The compulsory license granted to the exporting WTO Member (based on the national emergency or urgent circumstances in the importing WTO Member) will permit the exportation of t he amount sufficient to meet the needs of the importing WTO Member. 87 On December 5, 2005, the WTO General Council approved an amendment to TRIPS 82 Declaration on the TRIPS Agreement and Public Health para. 4, Nov. 14, 2001, 4th Session, Doha Ministerial Conference, Doc. WT/MIN(01)/DEC/2 [ hereinafter Doha Declaration]. 83 Id. at para. 5(b c). 84 Id. at para. 6. 85 Kerry, supra note 67, at 2. 86 Implementation of Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public He alth, Decision of 30 August 2002, p a r a 2 ( a ) ( i i ) Doc. WT/L/540 (entered into force Sep. 2, 2003) [ hereinafter Paragraph 6 Decision]. 87 Id. at para. 2(b)(i).

PAGE 35

35 (the first such amendment to a core agreement of the WTO) 88 to institute the TRIPS Article 31(f) waiver outlined in the Paragraph 6 Decision as a permanent part of TRIPS 89 The amendment goes into effect when two thirds of WTO members have ratified it; currently forty five out of one hundred fifty three members have ratified it, so the waiver in the Paragraph 6 Decis ion remains in effect. 90 The Doha Declaration and the waiver delineated in the Paragraph 6 Decision were regarded very positively by public health advocates, 91 and the Amendment of the TRIPS Agreement is a noteworthy new exception to the patent protections o f TRIPS and constitutes remarkably potent recognition of the right to health by the WTO 92 Other pertinent flexibilities under TRIPS include parallel importation which arises under TRIPS and regulations, adopt measures necessary to protect public health and nutrition 93 Parallel importation is the importation by a third party of a product marketed in ano ther state by the patent holder and which competes with the product that the same patent 88 B ERTA E SPERANZA H ERNNDEZ T RUYOL & S TEPHEN J. P OWELL J UST T RADE : A N EW C OVENANT L INKING T RADE AND H UMAN R IGHTS 132 (2009). 89 WTO, Amendment of the TRIPS Agreement, WT/L/641 (Dec. 8, 2005), available at http://www.wto.org/english/tratop_ e/TRIPS_e/wt1641_e.htmT/L/641 [ hereinafter TRIPS Amendment]. 90 Members accepting amendment of the TRIPS Agreement, WTO (Nov. 5, 2 012), http://www.wto.org/english/tratop_e/TRIPS_e/amendment_e.htm. 91 Kerry, supra note 67, at 3. 92 H ERNNDEZ T RUYOL supra note 8 8 at 133. 93 TRIPS, supra note 70, at art. 8(1).

PAGE 36

36 holder imports or produces locally. 94 Parallel importation is effective in combating price discrimination between markets of states in which there is large price discri mination for the same product. 95 The patent holder is still compensated in the state in which the product was first sold. 96 Another flexibility, which arises under TRIPS Article 30, is the research and experimental use exception, permitting generics manufact urers to the patent, with the objective of inventing new products that achieve the same purpose or improvements to the current product. 97 A final flexibility is that reg arding the use of marketing approval test data by generic manufacturers; this test data exception is rooted in TRIPS Article 39(3): pharmaceutical products the submission of undisclosed test or other data, the origination of which involves a considerable effort, shall protect such data against unfair commercial use. In addition, Members shall protect such data against disclosure, except where necessary to protect the public 98 This provision protects the test data underlying 99 Members shall 94 Charles T. Collins Chase, The Case Against TRIPS Plus Protection in Develo ping Countries facing AIDS Epidemics 29 U. P A J. I NT L L. 763, 773 (2008). 95 Id. 96 Id. 97 Id. at 773 74. 98 TRIPS, supra note 70, at art. 39(3). 99 Id.

PAGE 37

37 competition as provided in Article 1 0 bis of the Paris Convention 100 which defines ndustrial or commercial matters 101 Article 39 provides flexibility to Members in ascertaining how to precisely protect test data. 102 National hea lth authorities typically compel, as a stipulation for registering and efficacy as well as information on the composition and physical and chemical characteristics of 103 A significant number of health authorities do not oblige companies seeking registration of generic versions of the original product to repeat the studies that were previously executed but instead rely on bioequivalence tests to grant market ing approval. 104 use of the test data varies among states. 105 Obtaining this test data is monumentally expensive, and many generic producers will not enter the market until they are able to use the original data (or will not enter the market at all if they are never able to use it) ; alternatively, if they chose to gather their own test data, generic prices would likely increase substantially. 106 Therefore, limitations on test data exclusivity should b alance allowing originator companies to recoup their costs and fostering generic competition 100 TRIPS, supra note 70, at art. 39(1). 101 Paris Convention, supra note 6 3 at art. 10bis. 102 U TILIZING TR IPS F LEXIBILITIES FOR P UBLIC H EALTH P ROTECTION T HROUGH S OUTH S OUTH R EGIONAL Frameworks, WHO (2004), http://apps.who.int/medicinedocs/en/d/Js4968e/6.1.5.html#Js4968e.6.1.5. 103 Id. 104 Id. 105 Id. 106 Id.

PAGE 38

38 which serves public welfare through lower prices and increased availability and access to essential medicines. 107 Given this intersection of the right to health an d IPR, FTAs offer an avenue for fostering the implementation of TRIPS 108 However, the provisions in FTAs between the U.S. and Latin American states have executed that mandate to varying degrees. The following sections will look at the TRIPS between the U.S. and Latin American states and their corresponding human rights impacts. Section 3: TRIPS plus provisions: Chilean FTA and CAFTA DR Many FTAs entered into by the U.S. and other states (including the U.S. Chilean FTA (Chilean FTA) and the Dominican Republic Central America U.S. FTA (CAFTA DR)), incorporat e TRIPS plus provisions which are provisions which either limit the flexibilities found in TRIPS or surpass the requirements of TRIPS 109 These provisions, designed by the pharmaceutical industry to constrain availability of affordable medicines, were insert ed in FTAs by the U.S. in exchange for providing the other state with WTO 107 Id. 108 Collins Chase, supra note 9 4 at 775. 109 Susan K. Sell, TRIPS Plus Free Trade Agreements and Access to Medicine 28 L IVERPOOL L. R EV 41, 52 (2007).

PAGE 39

39 provisions; (2) prohibitions of parallel importation; (3) linkage between drug registration and patent protec 110 TRIPS plus Provisions: Data Exclusivity Turning first to data exclusivity provisions, these provisions operate independently from patent protections and delineate limitations to generic clinical test data underlying the patents/marketing approvals of brand name drugs. Some brand name producers only apply for marketing approval of a particular pharmaceutical, not a patent, in certain states. There are fewer standards and safeguards in the marketing approval process, and for such approval, manufacturers need only submit their clinical test data for approval. 111 When there are data exclusivity rules in place, marketing approval also offers an easier and faster way to prevent generic competitio n. 112 As producing clinical test data is a considerable expense, a generic manufacturer can apply for permission to market a generic version of a drug after the expiration of the b ioequivalent [to the brand name drug] (that the generic drug will work the same in the human body as the brand 113 If the brand name producer only applied for a pply forthwith. 110 Id. at 59. 111 Rohit Malpani, All costs, no benefits: How the US Jordan free trade agreement affects access to medicines 6 J. G ENERIC M ED 206, 209 n.3 (2 009). 112 Id. 113 Christine A. Chung, Create an Ominous Impact on Life Saving Medicines 13 S W J. L. & T RADE A M 171, 184 (2006).

PAGE 40

40 Under the Chilean FTA and CAFTA DR, brand name pharmaceutical producers are mandated to submit undisclosed clinical trial data as part of the drug marketing approval process, but Chilean FTA Article 17.10.1 114 and CAFTA DR Article 15.10.1(a ) 115 prohibit generic manufacturers from using that clinical trial data generated by brand name producers to obtain marketing approval for at least five years after the brand name drug is marketing approved which delays and may even prevent generic competit ion due to the high costs of producing test data which generic manufacturers typically cannot afford. 116 Compelling generic manufacturers to conduct their own authori 117 and many may choose not to enter the market at all 118 CAFTA TRIPS plus provisions. First, Article 15(10)(1) requires s tate parties to prohibit the approval of generics using clinical test data already submitted in any other state for five years; after submitting a drug for marketing approval in any state, the producer has five years to submit the drug for marketing approv al in CAFTA DR state parties. 119 Therefore, the 114 United States Chile Free Trade Agreement, U.S. Chil e, art. 17.10.1, Jan. 1, 2004, available at www.ustr.gov/assets/Trade_ Agreements/Bilateral/Chile_FTA/Final_Texts /asset_upload_file912_4011.pdf [ hereinafter Chilean FTA]. 115 Dominican Republic Central America U.S. Free Trade Agreement, art. 15.10.1.a., M ay 28, 2004, available at www.ustr.gov/assets/Trade_ Agreements/Regional/ CAFTA/ CAFTA DR_Final_Texts/asset_upload_file934_3935.pdf [ hereinafter CAFTA DR]. 116 Sell, supra note 109, at 60. 117 Id. 118 Chung, supra note 113, at 184. 119 CAFTA DR, supra note 115 a t art. 15(10)(1).

PAGE 41

41 manufacturer is able to acquire up to ten years of data exclusivity up to five years based on the date of approval in any state and then five years based on the dates of approval in CAFTA DR states since the approval. 120 Furthermore, restrictions only concern unfair commercial use 121 or the exception to protecting t est 122 Seco ndly, while TRIPS Article 39.3 applies protections to clinical test data define), 123 CAFTA DR Article 15(10)(1) (c) dictates that data exclu sivity applies to test data fo r new product [which] is one that does not contain a chemical entity that has been previously approved in the territ ory of the [state p] arty 124 Therefore according to CAFTA DR a chemical entity does not necessarily have to be new, allowing for marketi ng exclusivity to be granted for test data of older drug formulations which are already in public use when approval is sought in a CAFTA DR state party 125 O f crucial significance to the effect of this provision is the precise articulation of the definition of a new product for purposes of data exclusivity in the implementing national legislation for CAFTA DR in each state party In the DR, El Salvador, and Honduras, a new product is 120 Chung, supra note 113, at 185. 121 Abbott, supra note 80 at 98. 122 TRIPS, supra note 70, at art. 39(3). 123 P EDRO R OFFE TRIPS I SSUE P APER 4: B ILATERAL A GREEMENTS AND A TRIPS PLUS WORLD : THE C HILE USA F REE T RADE A GREEMENT 14 (2004), availa ble at http://www.quno.org/geneva/pdf/economic/Issues/Bilateral Agreements and TRIPS plus English.pdf. 124 CAFTA DR, supra note 115 at art. 15(10)(1)(c). 125 Cowley, supra note 42, at 242.

PAGE 42

42 does not contain chemical entities previously approved in the country both entities which have been previously approved and entities which have not been previously approved is not deemed to be new and will not receive data exclusivity for its test data. 126 However, a new pr contains a chemical entity not previously approved in the country 127 Hence, in th ose three states, a product that encompasses both entities which have be en previously approved and have not been previously approved is deemed to be new and will receive data exclusivity. Thirdly while the CAFTA Side Letter, Understanding Regarding Certain Public Health Measures, states that CAFTA DR's provisions do not hin der access to the TRIPS restricts access to only those measures meeting a necessity standard: measures necessary to protect public health in light of an epidemic, national 128 This provis ion is in direct violation with the Doha Declaration which affirmed that each WTO Member has the rig ht to grant compulsory licenses and to ascertain what grounds tho s e licenses shall be granted on 129 but t he CAFTA Side Letter adds factor for the proper iss uance of a compulsory license. In prior challenges to state has h ad to meet a two pronged test: first, it 126 Alejandro Cern & Angelina Snodgrass Godoy, Intellectual property and access to medicines: an analysis of legislation in Central America 87 B ULL W ORLD H EALTH O RGAN 787, 790 (2009). 127 Id. 128 Cowley, supra note 42, at 244. 129 Doha Declaration, supra note 8 2 at para. 5(b).

PAGE 43

43 must show that, to be necessary, the measure is e ffective and that no less trade restrictive measure is available to achieve the same purpose if proven to be necessary, [the state must] show that the proposed public health measure does not disguised res arbitrary or u njustifiable discrimination 130 Additionally the CAFTA Side Letter strips CAFTA DR state parties of their abilities t o issue compulsory licenses in cases of which is one of the listed grounds for issuance of a compulsory licen se in TRIPS Article 31(b) and a crucial tactic for providing low cost generic products to the public 131 In whole, these CAFTA DR provisions and their implementing legislation serve to extend data exclusivi ty (and create the possibility for data exclusivity to expire in the U.S. but continue in CAFTA DR state parties for up to an additional five years), bar CAFTA DR state parties from issuing compulsory licenses for public, non commercial use, and constrain abilities to issue th e se licenses und er extremely urgent circumstances, epidemics, or national emergencies. TRIPS plus Provisions: Prohibitions on Parallel Importation, Patent Linkages, and Patent Term Extensions Looking first at prohibitions on parallel importation, parallel importation is a crucial TRIPS pharmaceuticals in foreign markets at lower prices. 132 Under TRIPS states are free to 130 E LLEN R. S HAFFER AND J OE B RENNER CAFTA S IDE L ETTER DOES NOT PROTE CT A CCESS TO M EDICINE : CPATH B RIEF C ENTER FOR P OLICY A NALYSIS ON T RADE AND H EALTH 1 2 (2004), available at http://www.twnside.org.sg/title2/FTAs/Intellectual_Property/IP_and_Access_to_Medicines/CAFTASideLett erDoesNotProtectAccessToM edicines.pdf 131 TRIPS, supra note 70, at art. 31(b). 132 R UTH M AYNE R EGIONALISM B ILATERALISM AND THE P LUS A GREEMENTS : T HE T HREAT THE D EVELOPING C OUNTRIES : H UMAN D EVELOPMENT R EPORT 2005 16, available at http://hdr.undp.org/en/reports/global/hdr2005/ papers/HDR2005_Mayne_Ruth_18.pdf.

PAGE 44

44 set their own rules for parallel importation. 133 exha importation of the patented product from another state, significantly curtailing the prospects for parallel importation. 134 However, under an international exhaustion regime, the patent holder may not prohibit parallel importation, and the government is free to buy the patented pharmaceutical in other states and import it. 135 The TRIPS plus provisions found in FTAs between the U.S. and Singapore, Morocco, and Jordan establish national exha ustion regimes in all state parties; 136 however, these provisions are not found in the Chilean FTA or CAFTA DR 137 Secondly, the linkage between patent protection and drug registration found in the TRIPS plus provisions of the Chilean FTA Article 17.10.2(c) 138 and CAFTA DR Article 15.10.2(a) 139 necessitates that a holder of a patent in one state must give consent for registration and marketing approval of a generic based on that patented product in another state in which it is not patented. 140 This provision greatly inhibits generic production and other linkage provisions further delay access to generics by 133 Id. 134 Sell, supra note 109, at 61. 135 Id. 136 Id. 137 Parallel Imports and Border Measures in DR/CAFTA M ANAGING I NTELLECTUAL P ROPERTY (May 1, 2009), http://www.managingip.com/Article/2192547/Parallel imports and border measu res in DRCAFTA.html. 138 Chilean FTA, supra note 1 1 4 at art. 17.10.2(c). 139 CAFTA DR, supra note 115 at art. 15.10.2(a). 140 Sell, supra note 109, at 62.

PAGE 45

45 delineating that generic producers must wait until the patent expires to begin the registration and approval processes, instead of completing the processes before the patent expiries and being able to commence production immediately upon the patent expiration. 141 ric until the agency conducts sufficient resea rch to certify that no patent would be violated by the marketing approval of the generic (instead of relying upon patent holders to use the judicial system to bring causes of action for violations of their patents) 142 And thirdly, a nalyzing patent term ex tensions, TRIP plus provisions delineate that state parties to CAFTA DR in Article 15.9.6(a b) 143 and the Chilean FTA in Articles 17.9.6, 17.10.2(a) 144 are required to extend the life of a patent beyond the twenty years dictated in TRIPS easonable delays in the issuance of the patent 145 With slower bureaucratic progress in Latin American states, these extensions harm the public and foster uncertainty among generic producers. 146 141 Id. 142 Rangel, supra note 6 at 402; Henry A. Waxman, Remarks of Rep. Waxman on the Fifth Anniversary of I NFO J USTICE (May 15, 2012), http://infojustice.org/archives/23270. 143 CAFTA DR, supra note 115 at art. 15.9.6(a b). 144 Chilean FTA, supra note 1 1 4 at arts. 17.9.6, 17.10.2(a). 145 Rangel, supra note 6 at 402. 146 M AYNE supra note 1 3 2, at 14.

PAGE 46

46 U.S. Jordan FTA As the U. S. entered into a TRIPS plus FTA with Jordan (Jordanian FTA) in 2001, there is more data available regarding the human rights impacts of the TRIPS plus provisions than in Chile or the CAFTA DR area 147 Jordan was effectively the first state to implement the TRIPS plus rules. 148 Between 2001 and 2006, Jordanian citizens have been negatively affected by the higher drug prices resulting substantially from the Jordanian FTA. 149 medicines have shot up in the past few years and that the high cost of the medication at 150 A 2007 Oxfam study concluded that TRIPS consu mers could have sav ed between $9.45 million and $22.04 million (USD) or between 20.5% and 47.9% of the accumulative cost of new medicines with no generic 151 Multinational pharmaceutical corporations are actively using data exclusivity rules; of 103 non patented pharmaceuticals introduced to Jordan since 2001, at least seventy nine percent are effectively shielded from generic competition by data exclusivity. 152 Comparing the costs of five top selling diabetic and cardiovascular 147 Collins Chase, supra note 9 4 at 793. 148 Malpani, supra note 1 1 1 at 207. 149 Hamed El Said & Mohammed El Said, TRIPS Plus Implications for Access to Medicines in Developing Countries: Lessons from Jordan United States Free Trade Agreement 10 J. W ORLD I NTELL P ROP 438, 460 n.6 (2007). 150 Id. at 461. 151 Id. 152 Malpani, supra note 1 1 1 at 209.

PAGE 47

47 medications in Jordan and Egypt (whi ch allows for unrestricted generic competition), the Jordanian prices were, on average, nearly 500% higher. 153 The market share of medicines in Jordan with no generic equivalent tripled from three percent to nine percent between 2002 and 2006. 154 Not only ar e there increases in prices but also decreases in accessibility; everything, now we cannot produce patented drugs anymore. We can only produce drugs that either come out of pat 155 There is no evidence of increased pharmaceutical availability as a result of the Jordanian FTA. 156 In fact, the Jordanian pharmaceutical sector shrunk (as has the share of Jordanian firms in the domestic pharmaceutical manufacturing industry) 157 since it was constrained to producing drugs past the patent protection period 158 The Jordanian FTA did not live up to the expectations of increased foreign direct investment (FDI) in the Jordanian pharmaceutical sect or; the majority of new medicines are imported, and foreign corporations are simply investing in facilities in which to aggressively sell those medicines in Jordan. 159 In contrast, Egypt, which implemented the minimum TRIPS obligations, received $223 million (USD) in FDI from foreign multinationals in its 153 Id. at 210. 154 Id. at 212. 155 El Said, supra note 1 4 9 at 462. 156 El Said, supra note 1 4 9 at 465. 157 Collins Chase, supra note 9 4 at 798. 158 El Said, supra not e 1 4 9 at 463. 159 Malpani, supra note 1 1 1 at 214.

PAGE 48

48 pharmaceutical manufacturing sector between 1995 and 2006, compared to virtually none in Jordan (providing evidence that implementing TRIPS Plus provisions is not necessarily correlated with increases in FDI and vice versa). 160 The higher prices of medicine to increase by 600% between 2002 and 2006 in hospitals, disproportionately harming the poor, and undermining the access to the r ight to health. 161 Effects of TRIPS P lus Provisions Analyzing the Chilean FTA, its TRIPS capabilities to foster availability of generic medicines during a health crisis. 162 Chilean pharmaceutical prices were expected to rise 75% on account of the TRIPS plus provisions. 163 However, since evidence from the U.S. Chile Free Trade Commission meeting in August 2011 shows that Chile has not truly implemented the patent linkage and data exclusivity provisions, 164 it is difficult to ascert ain their effects on prices, availability, and access. Turning to CAFTA Oxfam and MSF, CAFTA's intellectual property protections will give monopoly like 160 Id. 161 Id. at 215 16. 162 U.S. Chile Free Trade Agreement C ITIZENS T RADE C AMPAIGN http://www.citizenstrade.org/ctc/trade policies/existing trade agreements/other bilateral trade agreements/u s chile free t rade agreement/. 163 Rodrigo Pizarro, The Free Trade Agreement between the USA and Chile: An Instrument of U.S. Commercial Interests T HE IDEAS W ORKING P APER S ERIES P APER NO 02/2006 29 (2006), available at http://www.networkideas.org/working/oct2006/02_200 6.pdf. 164 At FTA Commission, U.S. Presses Chile On Brand name Drug Protections I NSIDE U.S. T RADE (August 25, 2011), http://mycommunity.pharm.chula.ac.th/download/news/019/At%20FTA%20Commission%20U.S.%20Pres ses%20Chile%20On%20Brand%20Name%20Drug%20Protecti ons%20_25%20Aug%2011.pdf.

PAGE 49

49 status to high priced, brand name drugs in po in Central America and the Dominican Republic; 165 many people in Latin America are unable to afford branded drugs and thus will have less practicable access to medicines 166 Without access to lower priced generics, g overnmental purc hases of medicines will either be constrained or require initial funding 167 The provisions of CAFTA DR encumber access to the flexibilities described in TRIPS and constrict execution of the public health commitments found in the Doha Dec laration. Having ratified the ICESCR, 168 the Latin American states of CAFTA DR are likely acting contrary to the call of the Committee on Economic, Social, and Cultural impa 169 By the likelihood of restricting access to drugs which were previously available, hindering the availability of generics in public noncommercial clinics, and encumbering the usage of compulsory licensing in the face of an eme rgency situation or urgent circumstances, these provisions are not underpinning the progressive realization of the right to health called for in the ICESER through conditions supporting a rising standard of health such as practicable access to essential me dicines, community healthcare facilities, and appropriate treatment 170 Having ratified the ICSECR, these states are bound to take steps towards a full realization of this right; 165 Chung, supra note 113, at 180. 166 Cowley, supra note 42, at 244. 167 Id. 168 ICESCR, supra note 2. 169 ICESCR General Comment 14, supra note 2 9, at 14(39). 170 Id. at ICESCR General Comment 29 (17).

PAGE 50

50 CAFTA DR is pushing them in the opposite direction. 171 Under a human rights impac t 172 Looking specifically at the Dominican Republic (DR), eighty percent of the incr eases in the prices of pharmaceuticals between 2007 and 2027 is expected to be a direct result of data exclusivity. 173 Due to these cost increases, the Dominican government will likely face critical dilemmas in providing its citizens with access to the medic ations necessary to execute the right to health. 174 Turning to Guatemala, a study analyzing the effects of data exclusivity showed cancer, hypertension, myocardial infarc tion, leukemia, and herpes have been denied marketing approval in Guatemala based on the patents for the brand name drugs in other states 175 Furthermore, generic drugs for treating arthritis, hepatitis B, fibromyalgia, epilepsy, angina, hypertension (based on Ventavis ), cancer (Fludara Aloxi Emend and Erbitux ), pneumonia (Invanz ), diabetes (Lantus ), cardiac disease and stroke (Crestor ), and contraceptives (Yasmin) are not shielded by patents but are prohibited from approval (using brand name produ 171 Cowley, supra note 42, at 231. 172 See Walker, supra note 7 at 188. 173 G EORGETOWN H UMAN R IGHTS A CTION / H UMAN R IGHTS I NSTITUTE F ACTFINDING R EPORT (2010) 6, available at http://www.law.georgetown.edu/ news/releases/documents/FrequentlyAskedQuestionsDR.pdf. 174 Id. 175 Ellen R. Shaffer & Joseph E. H EALTH A FF 957, 961 n.5 (2009).

PAGE 51

51 Guatemala based on data exclusivity. 176 What is more, forty two of these generics are approved and sold in the U.S. based on the brand prohibited from being approved in Guatemala! 177 The prices o f numerous antibiotics are more than 300% higher than their generic barred by data exclusivity. 178 Looking specifically at insulin, brand named Lantus costs $50.31 (USD) per 100 mL, while a therapeutically equivalent generic insulin manufactured by Drogueri a Pisa de Guatemala costs $5.95 per 100 mL; as the clinical data supporting Lantus is shielded by data exclusivity until 2016, Guatemalans will pay 846% more for insulin than they clinical data 179 The generic prot ease inhibitor (to treat HIV), l opinavir, was retroactively banned due to data exclusivity; the imported branded form, Kale tra costs 166% more. 180 Four drug companies that formerly sold registered generic versions of clopidogrel bisulfat e [which is used to treat myocardial infarctions] in Guatemala have had that registration revoked after Plavix was granted data exclusivity 181 Examining Costa Rica, a study undertaken by the Costa Rican pharmaceutical industry estimates that CAFTA DR prov 176 Id. at 962; Ellen Shaffer, Joseph Brenner, & Shayna Lewis, CAFTA: Barriers to Access to Medicine in Guatemala, H EALTH AND H UMAN R IGHTS (Nov. 23, 2009), ht tp://www.hhropenforum.org/2009/11/cafta barriers to access to medicines in guatemala/. 177 Shaffer, supra note 1 7 5 at 964. 178 Id. at 962. 179 Shaffer, supra note 1 7 6 180 Shaffer, supra note 1 7 5 at 964. 181 Shaffer, supra note 1 7 6

PAGE 52

52 182 Costa Rica not only has ratified the ICESCR but also recognizes the right to health under its national constitution and provides access to essential medicines through the Caja Cos tarricense de Seguro Social (CCSS) (Costa Rican Social Security Fund). 183 Furthermore, federal legislation lays out the rights to access health services, receive medications, and bring claims for violations of the right to health (such as lack of access to e ssential medicines) to the national health institution or to the federal courts through the amparo constitutional rights have been violated by the state). 184 The latter offers quicker relief, but the former has more speci alized knowledge and funding for investigation to effect large scale changes. 185 Constitutional Chamber) held that CCSS must provide antiretroviral medications based on international human rights law; Costa Rica was also the first Central American state to guarantee access to healthcare to those with HIV/AIDS. 186 Many argue that CAFTA promote public health and provide medications (including antiretrovir al medications), generic medicines due to the strict provisions of CAFTA[ DR], Costa Rica's universal 182 Chung, supra note 113, at 176 183 Walker, supra note 7 at 195 96. 184 Id. 185 Id. at 196. 186 Kate E. Kaiser, The Fight for Access to AIDS Medications: How the Central American Free Trade 25 W IS I NT L L.J. 535, 542 43 (2007).

PAGE 53

53 187 CCSS saves 97% of the cost of brand name drugs by purchasing generics; the monthly cost of generic antiretroviral medications in Costa Rica is less than $200 (USD) as opposed to $625 for brand name drugs. 188 Moreover, when the antiretroviral n elfinavar was first offered by CCSS after the Sala Cua aforementioned decision in 1997, data exclusivity provisions would have been in effect until 2002. 189 The additional costs of the brand name drug (Viracept ) for those five years would have been $3.66 million. 190 This is a very substantial amount, especi ally 191 In fact, under CAFTA increase from 8% to 45%. 192 As of 2000, CCSS provided healthcare coverage to 90% of th e population; with increased costs of medications (estimated at 800%), either the government will direct more funds to healthcare or the quality of coverage or quantity of persons covered will diminish. 193 Regardless, neither access to healthcare by Costa R supported. 187 Paulette L. Stenzel, Free Trade and Sustainability through the Lens of Nicaragua: How CAFTA should be Amended to Promote the Triple Bottom Line 34 W M & M ARY E NVTL L. & P OL Y R EV 653, 694 (2010). 188 Kaiser, supra note 1 8 6 at 550 51. 189 Id. 190 Id. at 551. 191 Id. 192 Alberto R. Coll, Wielding Human Rights and Constitutional Procedure to Temper the Harms of 33 U. P A J. I NT L L. 461, 529 (2011). 193 Id.

PAGE 54

54 Based on this evidence, the provisions of CAFTA DR are not supporting Central the right to health through progressive realization. These provisions cultivate neither an to advance that access. Proposals for amending CAFTA DR in order to sh ift its impact and Peru Several Democratic congressional leaders, i ncluding Representative Charles Rangel, expressed concerns that the provisions in U.S. trade agreements and trade policies were not fairly spreading the benefits of globalization to developing states. 194 Through the House Ways and Means Committee, they struc 195 This policy delineates provisions which ought to be incorporated into future trade agreements, and the topics addressed by these provisions includ e access to medicine. 196 TRIPS 197 TRIPS plus provisions in CAFTA DR regarding data excl usivity, 194 Rangel, supra note 6 at 377. 195 Id. at 377 78; USTR to push for 12 years of Data Exclusivity for Biologics in TPPA supra note 6 196 Rangel, supra note 6 at 377 78, 400. 197 Id. at 401.

PAGE 55

55 198 Regarding data exc lusivity, the five year period would commence from the date which the drug was approved in the U.S., as long as the other state approves the drug within six months of the application date (thus encouraging an efficient approval process). 199 Thus, brand name manufacturers c ould no longer benefit from waiting years to apply for approval in a developing state and then having the five year data exclusivity period commence from that later application date. 200 However, once the generic version of a drug is available in the U.S., it must also become available in any state party that is classified as a developing state. 201 Regarding TRIPS plus provisions for patent extensions fo applications and marketing approval applications expeditiously with a view to avoiding 202 Looking at linkage, TRIPS plus provisions call for a drug regulatory agency to confirm that no patent would be violated before approving a st onl y provide preliminary injunctions for the expeditious adjudication of disputes concerning the 198 Id. 199 Id. at 404. 200 Id. 201 Waxman, supra note 1 4 2 202 Rangel, supra note 6 at 402.

PAGE 56

56 203 Therefore, access to generics is timelier, and patent holders have a manner of recourse for allegations of violation. 204 However, the onus is on the patent holder to bring a claim alleging violation of patent instead of forcing the drug regulatory agencies to serve as understanding that the FTA should be interpreted and implemented in a way supportive at the FTA does not prevent any state from executing measures to protect public health through fostering access to medicine under circumstances including ( but not limited to ) epidemics, national emergencies, or urgent circumstances. 205 Before ratification, the final texts of the U.S. FTAs with Peru, Panama, and regarding pharmaceuticals. 206 Looking first at Peru, in its national legislation allowing for the national judiciary to implement the provisions of the U.S. Peru FTA, there are no requirements for patent extension, and there are provisions for U.S. parties to challenge patent violations by generics (and compelling the Peruvian government to determine within 180 days if ther e has been a patent violation). 207 The data exclusivity rules 203 Id. at 403. 204 Id. 205 Id. at 404 05. 206 Mara F. Jorge, The Peruvian implementation of the US Peru FTA: A model for the world with room for improvement 7 J. G ENERIC M ED 40, 40 n.1 (2010); USTR to push for 12 years of Data Exclusivity for Biologics in TPPA supra note 6 207 Jorge, supra note 2 0 6 at 43 44.

PAGE 57

57 applies to new chemical entities which do not include different uses of a previously registered drug, mere comb inations of previously developed chemical entities, or changes in formulation, administration, or dosage. 208 Generic manufacturers are permitted to use clinical data which would be barred under data exclusivity to obtain marketing approval in order to enter the market precisely when the data exclusivity period ends. 209 Data exclusivity also does not apply to issuances of compulsory licenses or national measures to protect public health or address situations of national emergency or extremely urgent circumstance s. 210 Compulsory licenses may only be period of time. 211 Under the U.S. FTAs with Colombia and Panama data exclusivity rules also approved in the U.S. as long as the other state party approves the drug within six mon ths of the application in that state ). 212 Notably, data exclusivity does not apply to cases of public non commercial use (as well as national emergencies) or to 208 Id. 209 Id. at 44 45. 210 Id. at 46. 211 Id. 212 United States Colombia Trade Promotion Agreement, U.S. Colom., art. 16.10.2(b c) Nov. 22, 2006 (entered into force May 15, 2012), available at http://www.ustr.gov/tra de agreements/free trade agreements/colombia fta/final text [ hereinafter U.S. Colombia FTA]; United States Panama Trade Promotion Agreement, U.S. Panama, art. 15.10.2(b c), June 28, 2007, (entered into force Oct. 31, 2012), available at http://www.ustr.gov /trade agreements/free trade agreements/panama tpa/final text [ hereinafter U.S. Panama FTA]; J.F. H ORNBACK T HE U.S. P ANAMA F REE T RADE A GREEMENT C.R.S. D OC 7 5700, R32540, at 22 23 ( Oct. 27, 2011), available at http://www.fas.org/sgp/crs/row/RL32540.pdf

PAGE 58

58 pharmaceutical products which do not encompass new chemical entities. 213 C ompulsory her circumstances of public use 214 Therefore, the provisions found in these FTAs provide an avenue for more positive human rights impacts than those of TRIPS plus. Through more timely access to generic drugs, Central Americans will have increased access to affordable drugs, and Central American governments will be able to provide more medications to their populations and higher quality healthcare, within their monetary constraints. Section 5: Future Changes Since the provision human rights impact, Central American states, NGOs, and individual Americans who wish to foster access to human rights ought to push for an amendment to CAFTA DR in order to bring its provisions U.S. circumstances allow for compulsory licensing and that data exclusivity does not apply to public non commercial use. As the am endment process may be lengthy, Central American states could promote a more timely short term solution through an additional or amended side letter by the U.S. which would expressly allow the signatory states to determine themselves which measures were n ecessary for public health and what 213 U.S. Colombia FTA, supra note 2 1 2 at art. 16.10.2(d e); U.S. Panama FTA, supra note 2 1 2 at art. 15.10.2(d e). 214 H ORNBACK supra note 2 1 2 at 22 23.

PAGE 59

59 the pharmaceutical is first approved in any state, allow for generic producers to pay a small sum for access to pharmaceutical test data in order to attain marketing approval and be in position to begin production as soon as the patent expires, and allow the government to issue compulsory licens es without the consent of the patent holder. 215 Costa Rica, Guatemala, and Nicaragua should take immediate action to amend their test data for products which encompass both chemical entities which have been and have not been previously approved is not subject to data exclusivity. 216 TRIPS plus provisions ma y not, at the present time, be completely executed, the U.S. is pressuring Chile to execute legislation to implement stricter patent linkage and data exclusivity. 217 Chilean President Sebastin Piera has hinted that he may support such legislation. 218 However it could have a significantly negative human rights impact in Chile. Moreover, there is a considerable danger facing the positive human rights impacts of the Chilean and Peruvian FTAs: the Trans Pacific Partnership (TPP) trade agreement, to which Chile and Peru are parties to the ongoing negotiations of. 219 A leaked draft from the closed negotiations in Chicago in September 2011 showed that 215 Cowley, supra note 42, at 247; Shaffer, supra note 1 7 5 at 965. 216 See Cern, supra note 1 2 6 at 79 0. 217 At FTA Commission, U.S. Presses Chile On Brand name Drug Protections supra note 1 6 4 218 Id. 219 Access to Lifesaving Generic Medicines Threatened by US Trade Pact D OCTORS W ITHOUT B ORDERS (Sep. 8, 2011), http://www.doctorswithoutborders.com/press/relea se.cfm?id=5519&cat=press release.

PAGE 60

60 official noted that times h not directly applicable. 220 twelve year data exclusivity period (though more recent sources have said that the U.S. position has shifted to seven years ) requ isite patent linkage (the holder of a patent in one state must give consent for registration and marketing approval of a generic based on that patented product in another state in which it is not patented), and twenty year minimum period for patents with e xtensions granted due to marketing and patent approval delays. 221 exclusivity period commences from the date which the drug was approved in the U.S. as long as the other state approves t he drug within six months of the application date (thus encouraging an efficient approval process). 222 Thus, brand name manufacturers may be able to once again benefit from waiting years to apply for approval in a developing state and then having the data ex clusivity period in the developing state commence from that later application date. 223 Moreover, the provision delineating that once a generic version of a drug is available in the U.S., it must also become available in any state party that is classified 220 USTR to push for 12 years of Data Exclusivity for Biologics in TPPA supra note 6 221 Id. ; Access to Lifesaving Generic Medicines Threatened by US Trade Pact supra note 2 1 9 ; Liza Porteus Viana, Special Report : TPP Nego tiations To Heat Up In Melbourne Over Patents, Copyright, Medicines I NTELLECTUAL P ROPERTY W ATCH (Feb. 21, 2012), http://www.ip watch.org/2012/02/21/special report tpp negotiations to heat up in melbourne over patents copyright medicines/. 222 Waxman, supra note 1 4 2 223 Id.

PAGE 61

61 a s a developing state, has also been omitted. 224 Additionally, drug regulatory agencies the agency is able to certify that no patent would be violated by the marketing a pproval of the generic. 225 Similarly to CAFTA DR, data exclusivity (for a three year period) may be granted for adjusted dosages, new formulations (like extended release), or new uses of previously approved drug. 226 Fifteen members of Congress have written to USTR provisions. 227 support for the Doha Declaration including affirming that the TRIPS Agreement can and should be interpreted and implemented in a manner supportive of WTO members' 228 If the TPP is enacted in this form, it would demol ish the positive impact of the data exclusivity periods further than they currently would be. It is crucial that Peru and 224 Id. 225 Id. 226 C ITIZEN S T RADE C AMPAIGN (March 2012), http://www.citizenstrade.org/ctc/wp content/uploads/2012/03/TransPacificPublicHealth.pdf. 227 L ETTER TO USTR R ON K IRK FROM T EN M EMBERS OF C ONGRESS (Aug ust 2, 2011), available at http://infojustice.org/wp content/uploads/2011/08/Ten Representatives on TPP 08022011.pdf; L ETTER TO USTR R ON K IRK FROM F IVE M EMBERS OF C ONGRESS (September 8, 2011), available at http://infojustice.org/wp content/uploads/2011/09 /Five MOCs September 8 2011.pdf. 228 O FFICE OF THE U NITED S TATES T RADE R EPRESENTATIVE (July 20, 2012), http://www.ustr.gov/about us/press office/blog/2012/july/am bassador ron kirk trade access medicines.

PAGE 62

62 Chile advocate for changes or not sign the TPP, if it encompasses these provisions, in order to avoid negative human rights impacts and violations of the ICESCR. ticable access to the right to health within the TRIPS framework. As described, differing FTA provisions have varying impacts on the right to health. Therefore, CAFTA DR, the Chilean FTA, and right to health than TRIPS plus provisions. Increasing access to medicine will save millions of lives, increase the quality of life of millions more, and allow more to share and enjoy the benefits of scientific development.

PAGE 63

63 CHAPTER 3 IMPLEMENTATION OF COMPULSORY LICENSES TRIPS Plus in ize their flexibilities under TRIPS another concern arises and is the focus of this Chapter: how to encourage Latin American states (particularly the relatively less populous ones of Central America) to utilize these flexibilities under TRIPS such as the ability to issue compulsory licenses. The practicable capabilities of low and middle income Latin American states to issue compulsory licenses may be a key tactic in achieving affordable access to many types of medicines since nearly all pharmaceutical c ompanies price their products at the same price worldwide. 1 By not employing a price discrimination strategy based on per capita GDP for a particular pharmaceutical product, a deadweight loss often occurs since many consumers who would buy that product c annot afford to do so. 2 This deadweight loss could be decreased through selling that product to large numbers of persons in low or middle income states at lower prices (but still above the marginal cost of production). 3 Pharmaceutical companies could stil l recoup their R&D expenses and other fixed costs through selling the product at a higher price in high income states, and binding limitations on parallel imports of that product from lower income states with lower prices to high income states with higher 1 Jerome H. Reichman, Compulsory licensing of patented pharmaceutical inventions: evaluating the options 37 J. L AW M ED & E THICS 247, 251 n.2 (2009). Gilead implemented a global price discrimination strategy for pharmaceutical products that treat HIV, and the strategy has been much maligned by other pharmaceutical companies. Id. at fn. 50. 2 Id. at 251. 3 Id.

PAGE 64

64 abilities to earn a profit in higher income states. 4 However, a price discrimination strategy has not been implemented as pharmaceutical companies argue that persons in high income states would not be willing to pay $5 0 for a pharmaceutical product that was priced slightly above a marginal cost of $0.05 in a low income state even though it is common knowledge that a pharmaceutical company, to be profitable, must recoup its significant fixed costs and R&D expenditures. 5 products unavailable to scores of persons around the world, the number of states that have executed compulsory licenses has been relatively small, and Brazil and Ecuador are the on ly Latin American states to have done so for pharmaceutical products 6 Therefore, an analysis of the instances in which other states have implemented compulsory licenses and the legal, political, and economic constraints on issuing these licenses is essent ial to ascertaining the requisite steps that Latin American states must take in order to put them in the position of being able to feasibly issue compulsory licenses and viable strategies for executing those licenses. Section 1 examines these previously i ssued compulsory licenses, and Section 2 analyzes the perceived and actual constraints on issuing compulsory licenses. Section 3 discusses collaborative action, arguing that pooled compulsory licenses offer the most promising strategy for smaller Latin Am erican states to execute compulsory licenses and describing the steps that these states, when circumstances legitimately warrant, could take to issue 4 Id. 5 Id. 6 Reed Beall & Randall Kuhn, Trends in Compulsory Licensing of Pharmaceuticals Since the Doh a Declaration: A Database Analysis, 9 PL O S 1, 4 n.1 (2012).

PAGE 65

65 compulsory licenses collaboratively for a certain pharmaceutical product and use the waiver in the Paragra ph 6 Decision to import that product from another WTO member state which has the capability to manufacture it. Section 4 delineates the steps that Latin American states and possible exporter states could take in order to cultivate the necessary preconditio ns for such pooled licenses to be issued. Section 1: Compulsory Licenses in Action Since 1995, there have been fifteen episodes of compulsory licenses issued by twelve states: Brazil, Ecuador, Egypt, Ghana, Indonesia, India, Malaysia, Mozambique, Rwanda, Thailand, Zambia, and Zimbabwe. 7 Including episodes where a governmental intent to issue to a compulsory license was publicized but resulted in the state accepting a price discount or voluntary license from the pharmaceutical company, there have been at le ast twenty six instances in seventeen states: the aforementioned twelve plus Argentina, Canada, South Africa, Taiwan, and the U.S. 8 The majority of these episodes (sixteen), regarded compulsory licenses for pharmaceutical products treating HIV/AIDS, four t o treat communicable diseases (anthrax in Canada and the U.S., Hepatitis B in Indonesia, and pandemic flu in Argentina and Taiwan), and five for non communicable diseases (cancers in India and Thailand, coronary disease in Thailand, and erectile dysfunctio n in Egypt). 9 The majority of these episodes (fourteen in total) occurred in upper middle income states, which are defined as states with Gross National Income 7 Id. ; Vikas Bajaj & Andrew Pollack, India Orders Bayer to License a Patented Drug N.Y. T IMES (M arch 12, 2012), http://www.nytimes.com/2012/03/13/business/global/india overrules bayer allowing ge neric drug.html?src=recg; Sarah Boseley, Indonesia in bold move to obtain cheap drugs for HIV G UARDIAN (Oct. 11, 2012), http://www.guardian.co.uk/society/sarah boseley global health/2012/oct/11/hiv infection hepatitis b. 8 Beall, supra note 6 at 4. 9 Id ; Boseley, supra note 7

PAGE 66

66 (GNI) per Capi ta between $3,976 and $12,275 (USD ): Argentina, Brazil, Ecuador, Malaysia, South A frica, and Thailand. 10 Three occurred in the high income states of Canada, Taiwan, and the U.S. (GNI per capita of $12,276 or above), five in the lower middle income states of Egypt, Ghana, India, Indonesia, and Zambia (GNI per capita between $1,106 and $3, 975), and three in the low income states of Mozambique, Rwanda, and Zimbabwe (GNI per capita of $1,005 or below). 11 Six of these episodes occurred in 2001 2002, eleven in 2003 2005, and seven in 2006 2012. 12 The authors of Trends in Compulsory Licensing of Pharmaceuticals Since the Doha Declaration posit that these results are the consequence of upper middle income licenses (unlike many lower middle income and low income st ates) and the fact that donations of pharmaceutical products from NGOs are available to many low income states. 13 Additionally, upper middle income states are more likely to withstand the later discussed economic and political pressures from other states an d truly implement compulsory licenses; furthermore, many of these states were also facing the substantial financial burdens of treatment for HIV/AIDS and treatment for the non communicable diseases that HIV/AIDS patients are more susceptible to. 14 10 Beall, supra note 6 at 4; Data T HE W ORLD B ANK http://data.worldbank.org/about/country classifications/country and lending groups#Upper_middle_income (last visited August 2, 2012). 11 Beall, supra note 6 at 4; Data supra no te 10 12 Beall, supra note 6 at 4. 13 Id. at 6. 14 Id.

PAGE 67

67 The pert inent Latin American states are of upper middle income (Brazil, Chile, Costa Rica, Colombia, Dominican Republic, Ecuador, Panama, and Peru) or lower middle income (El Salvador, Guatemala, Honduras, and Nicaragua) with HIV adult prevalence rates between 0.3 % and 0.9% in 2011. 15 While these HIV prevalence rates are lower than those in the states that previously implemented compulsory licenses for HIV treating pharmaceutical products, the income classifications of these Latin American states may support the cap abilities of Latin American states to implement compulsory licenses. Additionally, as previously discussed, many Latin American states have constitutional responsibilities to provide essential medicines (including HIV treating antiretrovirals) to their pop ulations; if pharmaceutical prices impeded them from fulfilling them with an avenue for accomplishing those duties. Thailand Analyzing a few specific examples of imple mented compulsory licenses, Thailand implemented universal health coverage in 2001 and augmented that policy with establishing universal access to antiretrovirals for HIV/AIDS patients. 16 In April 2006, the Thai National Health Security Board established c riteria for issuing compulsory government to afford its citizens with universal access to essential medicines (listed in the National Essential Drug List) or be necessary in [an] emergency or a situation of 15 Data supra note 10 ; HIV/AIDS Prevalence Rates I NDEX M UNDI (2011), http://www.indexmundi.com/g/r.aspx?v=32. 16 Kristina M. Lybecker & Elisabeth Fowler, Compulsory Licensing in Canada and Thailand: Comparing Regimes to Ensure Legitimate Use of the WTO Rules 37 J. OF L AW M ED & E THICS 222, 227 n. 2 (2009).

PAGE 68

68 extreme urgency, or solve important public health problems, or help prevent and control 17 In November 2006 and January 2007, the Thai Ministry of Pu blic Health issued compulsory licenses for two antiretrovirals ( e favirenz and ritonavir ) and an anti clotting drug for coronary disease (clopidogrel). 18 The Ministry of Public Health stressed that it had engaged in fruitless discussions with the patent hol ders for two years before issuing the compulsory licenses; Merck (the holder of the patent for Sustiva (brand name e favirenz) denied that such discussions had occurred. 19 Thailand reasoned that the compulsory licenses were legally proper as the patent hold ers had violated the public interest by charging an 20 For instance, the annual price of e favirenz had been $500 ( USD ) which equaled one eighth of the average Th ai per capita annual income; at that price, the Thai government could only afford to provide it to one fifth of HIV patients in Thailand annually. 21 After implementing the compulsory license, the cost of providing e favirenz fell by 50%, 22 and Thailand remune rated to Merck payments equivalent to 17 Id. at 228. 18 Jakkrit Kuanpoth, Give the poor patients a chance: enhancing access to essential medicines through compulsory licensing 6 J. OF G ENERIC M ED 15, 18 n.1 (2008). 19 Id. at 19; Lybecker, supra note 16 at 228. 20 Kuanpoth, supra note 18 at 19; Yun Ching Yeh, Pharmaceutical Data Protection Law and Policy and Their Effects on the Right to Medicines: a Comparative Analysis 148 (2009) (d issertation, Golden Gate University School of Law), available at http://digitalcommons.law.ggu.edu/theses/25. 21 Kuanpoth, supra note 18 at 19; K RISHNA P RABHU & E RIC C ERVINI WHO C OMPULSORY L ICENSING : H ARVARD M ODEL C ONGRESS A SIA 2012 3, available at http:/ /hmcasia.org/wp content/uploads/2011/05/WHO_Compulsory Licensing.pdf. 22 HIV & AIDS in Thailand AVERT, http://www.avert.org/thailand aids hiv.htm (last visited July 4, 2012).

PAGE 69

69 e favirenz at the price of the generic version of e favirenz produced and sold in India at that time 23 In response, some pharmaceutical companies threatened to stop doing business in Thailand, and Ab bott (the patent holder of K a letra (brand name ritonavir ) ) announced in February 2007 that it would not introduce any new pharmaceutical products in Thailand. 24 Abbott followed through with that decision and was condemned by the UN, the Clinton Foundation, and Mdecins Sans Frontires which described the 25 Furthermore, Abbott investors such as Christian Brothers Investment Services and members of the Interfaith Center on Corporate Responsibility (which together owned $35 million in A bbott shares at that time) warned that the 26 Additionally, the U.S. and the EU argued that no compulsory license for a chronic condition like coronary disease was proper. 27 The U.S. further responded by placing Thailand on its Priority Watch List under Special 301 of the Omnibus Trade and Competitiveness Act of 1988 and threatened to revoke eralized System of Preferences. 28 This economic leverage had previously been successfully applied by the U.S. in 1992 to 23 Beall, supra note 6 at Appendix: Supporting Information Compulsory Licensin g Case Summaries 18. 24 Kuanpoth, supra note 18 at 19; P RABHU supra note 2 1 at 3 4. 25 Thomas Fuller, Thailand takes on drug industry, and may be winning N.Y. T IMES (April 11, 2011), http://www.nytimes.com/2007/04/11/world/asia/11iht pharma.4.5240049.h tml?pagewanted=2&_r=2. 26 Id. 27 Yeh, supra note 2 0 at 148. 28 Kuanpoth, supra note 18 at 19.

PAGE 70

70 encourage Thailand to amend its patent law to protect pharmaceuticals. 29 However, Thailand renewed these three compulsory licenses in 201 0 and issued two additional compulsory licenses for cancer drugs in 2007 and 2008. 30 Ecuador Examining the case in Ecuador in April 2010, Ecuador issued its first compulsory license for the antiretroviral ritonavir to Eskegroup SA, the domestic distributor of Cipla (an Indian generic pharmaceutical manufacturer). 31 The Ecuadorean Intellectual Property Office had communicated with Abbott (the brand name Kaletra patent holder) regarding its considered and then implemented plans to issue a compulsory license. 32 The compulsory license dictated that Eskegroup pay royalties to Abbott, calculated Remuneration guidelines for non voluntary use of a patent on medical technologies published by the United Natio for Essential Drugs and Traditional Medicine in 2005. 33 According to the TRM, the the price of the patented product in the high income country. The base royalty is 4 percent of the high income country price, which is then adjusted to account for relative income per capita or, for countries facing a particular high burden of disease, relative 29 Id. 30 Beall, supra note 6 at 4. 31 Catherine Saez, Ecuador Grants First Compulsory Licence For HIV/AIDS Drug I NTELL P ROP W ATCH (April 22, 2010), http://www. ip watch.org/2010/04/22/ecuador grants first compulsory licence for hivaids drug/. 32 Id. 33 Id.

PAGE 71

71 income per person with the disease [TRM] provides a more rational framework for sharing the costs of research and development and may be more sustainable for some middle or high income countries that are sensitive to global norms concerning the sharing of 34 As calculated according to TRM, Eskegroup remitted $0.041 (USD) in royalties to Abbott for each 100 mg capsule of ritonavir sold. 35 The price of ritonavir fell by 27% after the license was implemented and has continued to decrease, 36 allowing more HIV patients (less than half of HIV positive Ecuadorians received antiretrovirals before the license was issued) 37 Health ministers of other states in the South American Union of Nations (UNASUR) optimistic that its decision will encourage others. 38 Ecuador is also considering issuing a second compulsory license to another distributor for ritonavir, which is expected to cause the annual cost per person to fall further to $470 (USD) (as opposed to a $1000 annual cost before the first license was issued). 39 34 Id. 35 Id. 36 Beall, supra note 6 at Appendix: Supporting Information Compulsory Licensing Case Summaries 8. 37 Praise for Ecuador's grant of compulsory licen se for AIDS drug P EOPLE S H EALTH M OVEMENT (May 4, 2010), http://www.phmovement.org/en/node/2883. 38 Saez, supra note 31 39 Id. ; Praise for Ecuador's grant of compulsory license for AIDS drug supra note 37

PAGE 72

72 Brazil Turning to Brazil, in 1996, Brazil enacted a federal law to provide HIV positive 40 On several occasions, Brazil employed the threat of compulsory licenses to attain significant price concessions from patent holders of HIV/AIDS treating pharmaceutical products, resulting in some of the lowest prices of these prod ucts in the world and, by 2001, Brazil being able to provide treatment to 100,000 HIV patients. 41 As an example of these successful threats, in 2001, the Brazilian Minister of Health, Jos Serra, noted treating antiretroviral nelfinavir (brand name Viracept ) 42 As Roche earned a significant percentage of its revenue in Brazil (one of the ten largest pharmaceu tical markets in the world) and was aware that Brazil had the manufacturing capacity to produce the drug, Roche offered a forty percent discount on the price of Viracept ; Brazil accepted and saved $35 million (USD) per year (a significant cost saving as B antiretrovirals at that time was $305 million). 43 Successful price negotiations were also conducted with Merck, Abbott, and Gilead for price discounts of HIV treating products. 44 40 Senator Jos Serra, Minister of Health of Brazi l, Keynote address at AIDS 20 Years Later: An International Health Conference: Lessons from the Brazilian AIDS Program, (2001). 41 Id. ; T HE WTO D ECISION ON C OMPULSORY L ICENSING K OMMERSKOLLEGIUM : S WEDISH N ATIONAL B OARD OF T RADE 37 (2008), available at http ://www.kommers.se/upload/Analysarkiv/Arbetsomr%C3%A5den/WTO/Handel%20och%20skydd%20f %C3%B6r%20immateriella%20r%C3%A4ttigheter%20 %20TRIPS/Rapport%20The_WTO_decision_on_compulsory_licensing.pdf. 42 T HE WTO D ECISION ON C OMPULSORY L ICENSING supra note 41 at 37 38. 43 Id. at 37. 44 Id.

PAGE 73

73 However, in 2007, Brazil did execute a compulsory li cense for e favirenz 45 on the Article 71 of Brazilian law 9,279/96. 46 Brazil was only willing to pay the same price for the brand name drug (Sustiva ) as Merck had offered to low income states ($0.45 per pill), but Merck merely offered Brazil a 30% discount ($1.59 to $1.10). 47 The compulsory license dictates that 1.5% of royalties are to be remuner ated to Merck, and by issuing this five year compulsory license, Brazil has saved at least $40 million annually in providing e favirenz to its population 48 Brazil sets a strong (but not necessarily attainable by all) example for other states regarding comp ulsory licenses; Brazil domestically produces eight unpatented antiretrovirals for HIV (as well as many unpatented drugs for other diseases/conditions) and attempts to negotiate with patent holders for price discounts which are sufficiently substantial to make it feasible for the Brazilian government to incur the entire cost of the 45 Id. 46 T OPIC 10: T HE U SE OF C OMPULSORY L ICENSES (CL), R EGIONAL S EMINAR FOR C ERTAIN L ATIN A MERICAN AND C ARIBBEAN C OUNTRIES ON THE I MPLEMENTATION AND U SE OF S EVERAL P ATENT R ELATED F LEXIBILITIES 17 (2012), http://www.wipo.int/edocs/ mdocs/mdocs/en/ wipo_ip_bog_12/wipo_ip_bog_12_ref_u10c_binsfeld.pdf. The other conditions under which a compulsory license may be issued are abusive exercise of patent rights, abuse of economic power, non exploitation of the subject matter or the patent in the territory of Brazil, and commercialization that does not meet the market needs. Id. exploitation of the subject exclusive compulsory license for a pharmaceutical patented in Brazil if the patent holder fai ls to manufacture the patented pharmaceutical in Brazil within three years of the grant of the patent. Sharon Thach & Susan J. Marsnik, Patent Standards Under TRIPS and the Pharmaceutical Industries in Brazil and India, 10 L ATIN A M B US R EV 237, 247 n.4 Id. 47 T HE WTO D ECISION ON C OMPULSORY L ICENSING supra note 41, at 37, fn. 111; Beall, supra note 6 at Appendix: Supporting Information Compulsory Licensing Case Summaries 3. 48 Beall, supra note 6 at Appendix: Supporting Information Compulsory Licensing Case Summaries 3; Compulsory Licensing of Efavirenz in Brazil A CCESS TO P HARMACEUTICALS (2010), http://www.accesstopharmaceuticals.org/case studies in global health/efavirenz brazil/

PAGE 74

74 49 Brazil only executes compulsory licenses if these negotiations fail and has also successfully fra human rights to access to essential medicine and treatment for HIV. 50 Gleaning lessons from these examples for other Latin American states, goodwill is fostered by entering i the patented product that would allow for affordable access but would result in prices that are above the marginal cost. While prior failed negotiations with the patent holder for voluntary licenses are not requisite under TRIPS Article 31(b) for compulsory making an effort to is also valuable to frame the issue as one involving access to human rights and bolster that argument through limiting compulsory licenses to true public health concerns (as opposed to bargaining position with patent holders and its ability to execute a compulsory license, and strategies for bolstering those factors in other Latin American states will be discussed further. 49 Robert Bird & Daniel R. Cahoy, The Impact of Compulsory Licensing on Foreign Direct Investment: A Collective Bargaining Approach 45 A M B US L. J. 283, 316 n.2 (2008). 50 Id. at 314.

PAGE 75

75 Compulsory Licenses for Importation There is only one instance of a state implementing the waiver to TRIPS Article 31(f) (delineated in the Paragraph 6 Deci sion) as well as the 2005 Amendment to TRIPS 51 which makes the waiver a permanent part of TRIPS ). 52 As previously manufacturing capacities in the pharmaceutical sector import those products from another WTO Member State under compulsory licensing, and this instance involved Rwanda as the importing state and Canada as the exporter. 53 In May 2004, Canada enacted the Access to Medicines Act allowing Canada to apply for compulsory licenses to export certain pharmaceutical products to least developed or developing states that applied for a compulsory license for a product which they lacked sufficient manufacturing capabilities to produce dome stically. 54 It is the responsibility of the importing state to issue a compulsory license, notify the Government of Canada that it requires a particular pharmaceutical product which it is unable to produce, and then find a suitable Canadian pharmaceutical c ompany to produce and export the product. 55 In July 2007, Rwanda notified the WTO Secretariat of its intention to issue a compulsory license for generic Apo T riAvir (a fixed dose combination of three HIV/AIDS treating products) and import 15.6 million tabl ets from Apotex, a Canadian 51 WTO, Amendment of the TRIPS Agreement, WT/L/641 (Dec. 8, 2005), a vailable at http://www.wto.org/english/tratop_ e/TRIPS_e/wt1641_e.htmT/L/641 [ hereinafter TRIPS Amendment]. 52 Beall, supra note 6, at 7. 53 Id. 54 Lybecker, supra note 16 at 226. 55 Id.

PAGE 76

76 generic manufacturer. 56 Two months later (after the obligatory (under Canadian law) negotiations with the patent holders for a voluntary license proved fruitless), the Canadian Commissioner of Patents granted a compulsory license to Apotex, permitting it to manufacture the requested number of Ap o T riAvir tablets, exclusively for export to Rwanda over a period of two years. 57 R wanda received shipments of Apo TriAvir in September 2008 (6,785,640 tablets) and in September 2009 (7,628, 700 tablets). 58 Rwanda paid $0.39 per tablet (totaling around $5.3 million); the combined marginal costs for each tablet were $3 million, but Apotex incurred a loss once fixed costs, legal fees, expenses for receiving regulatory approval, costs of negotiati ng for a voluntary license, and the 2% of royalties remitted to the patent holders of the drugs encompa ssed in Apo TriAvir were taken into account. 59 Going forward, Apotex stressed that the Canadian Access to Medicines Act must be modified to work effectiv ely in the future. 60 The process was too cumbersome, and the manufacturer has few incentives to use this Act as it is not profitable to produce a product for merely one importing state since the maximum term of two years for the compulsory license does not allow the manufacturer to recoup its investment fixed 56 Holger P. Hestermeyer, Canadian made Drugs for Rwanda: The First Appl ication of the WTO Waiver on Patents and Medicines 11 ASIL I NSIGHTS 28 (2007), available at http://www.asil.org/insights071210.cfm#_edn1; G EORGE T SAI C ANADA S A CCESS TO M EDICINES R EGIME : L ESSONS FOR C OMPULSORY L ICENSING S CHEMES UNDER THE WTO D OHA D ECLARA TION available at http://accesstomedicineseminar.files.wordpress.com/2010/01/canada_s access to medicine_s regime2.pdf. 57 Hestermeyer, supra note 56 ; Tsai, supra note 56 at 17. 58 Tsai, supra note 56 at 18. 59 Id. at 18; WHO, C OUNTRY E XPERIENCES IN USING TRIPS S AFEGUARDS 3 (2008), available at http://www.searo.who.int/LinkFiles/IPT_Briefing_note_4_country_experiences.pdf. 60 Lybecker, supra note 16 at 227; Hestermeyer, supra note 56 ; Tsai, supra note 56 at 38.

PAGE 77

77 costs. 61 Apotex advocated for this Act to be amended to expand the list of medicines for which a compulsory license can be issued for export, streamline the onerously complicated and time consuming appl ication process, remove the two year limit on a the need for regulatory approval (which is not required for pharmaceutical products exported under non compulsory lice nses from Canada), and terminate the requisite negotiations for a voluntary license which are not required under TRIPS Article 31(b) for commercial u 62 TRIPS intentionally omitted the precondition of failed negotiations for a voluntary license from applying to compulsory licenses for government uses like public programs to provide antiretrovirals to low income populations in order to simplify, stand process. 63 Section 2: Constraints on Compulsory Licenses Legal and Political Constraints There are numerous factors inhibiting compulsory licensing from being utilized to its fullest potential. One of the most signifi misunderstanding that TRIPS allows for compulsory licensing only when there is an 61 Lybecker, supra note 16 at 227; Hestermey er, supra note 56 ; Tsai, supra note 56 at 30, 32, 35, 38. 62 Lybecker, supra note 16 at 227; Hestermeyer, supra note 56 ; Tsai, supra note 56 at 30, 32, 35, 38. 63 G LOBAL C OMMISSION ON HIV AND THE L AW : UNDP, R EGIONAL I SSUES B RIEF : I NTELLECTUAL P ROPERTY R IGHTS AND A CCESS TO M EDICINE A SIA P ACIFIC R EGIONAL D IALOGUE 4 (2011), http://www.ippacificislands.org/health/IssuesBrief_IPR.pdf.

PAGE 78

78 64 The legislation in many states delineating the conditions for that state to issue a compulsory license often do not en compass all of the possibilities allowed for by TRIPS reasonable commercial terms and conditions not obtained. 65 However, in Latin America, the pertinent states of Brazil, Colombia, Costa Rica, Dominican Republic, Ecuador, Guatemala, Honduras, Mexico, Nicaragua, Panama, and Peru all allow for compulsory lice nses to be issued for public interest/health (though there are im plicit limitations from the data exclusivity rules in FTAs delineated in Chapter 2 ); Chile and El Salvador are the only pertinent states which do not. 66 However, fewer states allow for a compu lsory license to be issued after 67 Among these states which are able to issue compulsory licenses for 64 Yves Cozien Papa Tchofou, Compulsory Licensing and Access to Medicines in the TRIPS compliant World: Policy Options for Ant i HIV Drugs in Sub Sahara Africa 55 (2011) (M.A. thesis, Hanken School of Economics), available at https://helda.helsinki.fi/bitstream/handle/10138/25952/papa.pdf;jsessionid=9B068FF89DC92076FBCEE5 8DC654433B?sequence=1. 65 Id. 66 Maria Auxiliadora Oliveira, Jorge Antonio Zepeda Bermudez, Gabriela Costa Chaves, & Germn Velsquez, Has the implementation of the TRIPS Agreement in Latin America and the Caribbean produced intellectual property legislation that favours public health? 82 B ULL OF THE W ORLD H EALTH O RG 815, 819 n.11 (2004); Industrial Property Registry, Patent Office Costa Rica WIPO, http://www.wipo.int/scp/en/exceptions/replies/costa_rica.html#Q9 (last visited July 5, 2012); Latin America: Compulsory Licensing Becomes Sexy M ANAGING I NTELLECTUAL P ROPERTY (April 1, 2002), http://www.managingip.com/Article/1321873/Latin AmericaCompulsory licensing becomes sexy.html. 67 Oliveira, supra note 325 at 66 ; Industrial Property Registry supra note 66 ; Latin America: Compulsory Licensing Becomes Sexy supra note 66

PAGE 79

79 compulsory licenses though they certainly may legally do so under international a nd national law. 68 As previously noted, the U.S. threatened Thailand with economic sanctions after Thailand implemented compulsory licenses, and to counteract pressure from other states, Brazil made concerted efforts to frame the public discourse regarding its compulsory licenses in light of the human right to essential medicines including antiretrovirals. 69 Economic Constraints FDI Another significant fear is that of diminished foreign direct investment (FDI) in states that issue compulsory licenses as pate 70 For instance, if a state issued a compulsory license, patent holding pharmaceutical companies could cancel or diminish planned investments in that state, refuse to introduce new pharmac eutical products in that state (like Abbott in Thailand), or even withdraw from that state. 71 However, one should keep in mind that, absent stringent data exclusivity rules, if a company introduces a new product but does not introduce it or patent it in a p articular state, that product would fall into the public domain of that state, and the state could reverse engineer that product and then tender 68 Tchofou, supra note 64 at 63. 69 Id. 70 Reichman, supra note 16, at 256. 71 Id.

PAGE 80

80 bids from generic pharmaceutical manufacturers to produce it. 72 If the state lacked sufficient manufacturing cap acity, it could issue a compulsory license and then appeal to another WTO member to also issue a license and export the product. 73 Looking at the effect of IP protection on FDI, the relationship is ambiguous as some states, like China, attract massive amoun ts of FDI, despite poor IP protection since the economic opportunities are so enticing. 74 However, other states with less attractive economic opportunities attract less FDI even if they have strong and well executed IP laws. 75 Brazil offers a positive exampl e of a state that has issued compulsory licenses but has attracted $2 billion (USD) in pharmaceutical FDI since it adopted its patent/compulsory license statutes in 1995. 76 The authors of The Impact of Compulsory Licensing on FDI reason that this is a funct clear and enforced methods for determining royalties, and issuance of compulsory licenses according to the conditions delineated in TRIPS and only to address true and 72 Id. at 257. However, under the Patent Cooperation Treaty (PCT), to which the U.S., Canada, and all states of Central and South America are contracting parties to ( except Argentina, Bolivia, Guyana, Paraguay, Suriname, Uruguay, and Venezuela), any citizen or resident of a Contracting State may seek patent protection for an invention simultaneously in any or all of the Contracting States by filing an Patent Cooperation Treaty ("PCT") (1970 ), PCT, http://www.wipo.int/pct/en/treaty/about.html (last visited Feb. 16, 2013). The PCT provides a 30 month period of time to patent applicants to evaluate the strength of their patent, determine marketing plans, and evaluate expenses of translation, national filing fees, and possible litigation in different states before selecting which additional states to file for patents in and incur the costs of filing fees. Id. If an applicant does decide to file with another national patent office within that 30 month period, then the filing date will be the date that he first filed in any other state, but if the patent is granted, the 20 year period of protection will run from the date that the applicant filed the PCT application. PCT P ATENT L ENS http://www.patentlens.net/daisy/KeyOrgs/1236/418/420/422.html (last visited Feb. 16, 2013). PCT contracting state could violate patent rights if the original patent applicant had filed a PCT application within the past thirty months. 73 Reichman, supra note 16, at 257. 74 Id. at 256. 75 Id. 76 Bird, supra note 49 at 316.

PAGE 81

81 significant public health needs. 77 Brazil was contraste d with Egypt which damaged its credibility by delineating in its statutes that a compulsory license may be issued for a pharmaceutical product purely if the price is too high to satisfy national demand, failing to establish a set method for calculating roy put forth in TRIPS ), a decidedly opaque process for approving compulsory licenses, and issuing a compulsory license f or erectile dysfunction in 2002. 78 In 2003, the Pharmaceutical Research and Manufacturers Association of America (PhRMA) informed Egypt that its IP laws, including its compulsory licensing statutes and execution of them, deterred PhRMA from investing $300 m pharmaceutical sector. 79 Similarly, South Africa in 1997 passed legislation that gave the Minister of Health unlimited discretion to issue compulsory licenses. 80 Forty multinational pharmaceutical companies responded by suing the government of South Africa to block the legislation on the grounds that it violated TRIPS and the U.S. government threatened sanctions. 81 Amidst public pressure by AIDS activists, the suits were eventually dropped two years later but had successfully delayed the imp lementation of the law and cost South Africa 77 Id. at 312 16. 78 Id. a t 304 08. 79 Id. at 308. 80 Robert C. Bird, Developing Nations and the Compulsory License: Maximizing Access to Essential Medicines While Minimizing Investment Side Effects 37 J. of L AW M ED & E THICS 209, 2 12 n.2 (2009). 81 Id.

PAGE 82

82 in both credibility and monetary resources expended to defend against the suits. 82 While the U.S. also has a very broad statute for allowing the implementation of compulsory licenses, it has a uniquely strong his tory of enforcing IP rights so that patent holders are not fearful. 83 However, in most other states, implementing statutes that permit a compulsory license to be issued without sufficient justification on public health grounds or that does not delineate a m ethod for calculating royalties to the patent holder foster mistrust between governments and patent owners. 84 Shadow pricing which is allowed to produce the pharmaceutical pro duct under the compulsory license barely undercuts the price of the brand name drug. 85 This issue can be fairly easily remedied through allowing for reverse bids for manufacturers to produce the product under a compulsory license, encompassing a price range for the product in the compulsory license, or allowing multiple manufacturers to produce the drug under the compulsory license. 86 Regarding possible negative effects on incentives to innovate by 82 Id. US criticism on this issue, President Bill Clinton signed the Executive Order on Access to HIV/AIDS Pharmaceutical and Medical Technologies, directing the US government to refrain from seeking the revocation of any law or policy imposed by a beneficiary s ub Saharan government to promote access to essential medicines. In 2001, the TRIPS Council examined the TRIPS Ashley Weber and Lisa Mills, A one time only combination: 12 H EALTH AND H UM R TS 109, 109 n.1 (2010). 83 Id. 84 Id. at 214. 85 Id. 86 Id.

PAGE 83

83 issuing compulsory licenses, pharmaceutical companies innovat e to achieve ex ante 87 exclusive rights to produce and sell the resultant patented product in developed states. 88 Presently, they typically expect to attain most (if not all) of their profits from sales in high lsory license being issued by a low or middle income states are not taken into account. 89 A similar concern in one state and exported to another under a compulsory license. To allay this fear, the 2005 Amendment to TRIPS Paragraph 2(b)(ii) of the Annex to the Amendment to TRIPS Article 31bis calls 90 To comply with this provision, the Canadian Access to Medicine Act calls for an y products exported under a compulsory license to be denoted by particular labeling, coloring, or markings. 91 take reasonable measures within their means, proportionate to their administrative 87 Ex ante ns that the exclusive right to sell is attained attempt to develop a new drug depends on a prospective analysis of future expected revenues, less future expected costs. 88 Reichman, supra note 16, at 257. 89 Id. 90 TRIPS Amendment, supra note 51 at Annex 2(b)(ii). 91 Lybecker, supra note 16 at 226.

PAGE 84

84 capacities to p revent re 92 and all WTO member states are compelled pharmaceutical products that were exported to another state under a compulsory license. 93 Domestic manufac turing capabilities Many Latin American states have limited domestic manufacturing capabilities for pharmaceuticals, and domestic production, even if developed, may not be economically viable. 94 Only Brazil and Mexico meet the prerequisites for a viable dom estic pharmaceutical industry: a population over 100,000,000 and GDP adjusted for Purchasing Power Parity (PPP) over $1 billion (USD). 95 The pharmaceutical markets of Brazil and Mexico are so much larger than those of other Latin American states that they account for two thirds of the total Latin American pharmaceutical market ($25 billion out of $38 billion). 96 high income states is very rare; Brazil, China, Egypt, Jordan, Pakistan, and the Philippines are th e only non Organisation for Economic Co operation and Development (OECD) 92 TRIPS Amendment, supra note 51 at Annex 3. 93 Id. at Annex 4. 94 Tchofou, supra note 64 at 56. 95 Data Pr ofile W ORLD B ANK http://web.worldbank.org/WBSITE/EXTERNAL/COUNTRIES/LACEXT/0,,contentMDK:22117191~pagePK :146736~piPK:146830~theSitePK:258554,00.html (last visited July 5, 2012); Report for Selected Countries, IMF, http://www.imf.org/external/pubs/ft/weo/ 2010/02/weodata/weorept.aspx?sy=2010&ey=2010&scsm=1&ssd =1&sort=country&ds=.&br=1&pr1.x=52&pr1.y=8&c=336%2C213%2C263%2C268%2C339%2C273%2C2 18%2C278%2C223%2C283%2C228%2C288%2C233%2C293%2C238%2C243%2C248%2C366%2C25 3%2C298%2C258%2C299&s=PPPGDP%2CPPPPC&grp=0&a= (last visited July 5, 2012). 96 C ASSANDRA S WEET & A NDREA L APLANE ECLAC, T HE L ATIN A MERICAN P HARMACEUTICAL S ECTOR : L EGAL AND C OMMERCIAL T RENDS IN THE P OST TRIPS E NVIRONMENT 8 (2010), available at http://ictsd.org/downloads/2010/03/sweet laplane presentatio n.pdf.

PAGE 85

85 those only Jordan and Brazil are net exporters. 97 Furthermore, other factors including compara tive advantage and the capital intensive nature of the industry (as opposed to labor intensive, therefore creating relatively fewer jobs) support smaller, low income or lower middle income states to concentrate their investment on other economic sectors. 98 Therefore, as many Latin American states will likely lack sufficient manufacturing capacities to produce most pharmaceutical products for the foreseeable future, feasibly executing a compulsory license will most likely involve using the waiver in the Para graph 6 Decision to issue a compulsory license for a pharmaceutical product and then importing it from another state. However, only a few states have enacted legislation to permit that state to issue compulsory licenses for a product to be exported: Canada China, the European Communities, India, Korea, the Netherlands, Norway, and Switzerland. 99 It is discouraging that many states, including the U.S. and Brazil, do not seem interested in enacting such legislation. 100 The problems with the Canadian Access to M yet to be actively used) were discussed previously, and any states which may consider enacting such laws in the future should learn from the Canadian Rwandan example by 97 W ARREN K APLAN AND R ICHARD L AING H EALTH N UTRITION AND P OPULATION D ISCUSSION P APER : L OCAL P RODUCTION OF P HARMAC EUTICALS : I NDUSTRIAL P OLICY AND A CCESS TO M EDICINES A N O VERVIEW OF K EY C ONCEPTS I SSUES AND O PPORTUNITIES FOR F UTURE R ESEARCH 10 1 ( J an. 2005), available at http://www.who.int /medicines/technical_briefing/tbs/KaplanLocalProductionFinal5b15d.pdf. 98 Id. at 9, 26. 99 Bryan Mercurio, Resolving the Public Health Crisis in the Developing World: Problems and Barriers of Access to Essential Me dicines 5 N W J. OF I NTL H UM R 1, 11 n.1 (2006). 100 Id. ; T HE WTO D ECISION ON C OMPULSORY L ICENSING supra note 41 at 28.

PAGE 86

86 ensuring t hat their laws encompass more simplified procedures than those in the Canadian legislation, license durations of more than two years, and the authority to issue compulsory licenses for export based on any of the permissible grounds in TRIPS (and not necess itate prior failed negotiations with the patent holder when such negotiations are not required in TRIPS ). 101 Future implementing legislation should also joint consideration of concurrent licenses on multiple drugs and for multiple 102 as unlikely that any company in Europe would be able to serve as exporters [for a compulsory license], if the market was restricted to one country and there is no long term market prospect 103 Section 3: Collaborative Action One of the most promising strategies for Latin American states to viably issue compulsory licenses is through collaborative action. If a number of Latin American states collectively negotiated contracts with pharmaceutical companies and coordinated their issuance of compulsory licenses for particular products, they could generate economies of scale and scope to bolster their bargaining positions with both patent holders and producers of generic or off patent products. 104 Ad ditionally, collective action would hamper retaliatory actions from other states or actors for issuing 101 B ROOK K. B AKER A RTHRITIC F LEXIBILITIES : A NALYSIS OF WTO A CTION R EGARDING P ARAGRAPH 6 OF THE D OHA D ECLARATION ON THE TRIPS A GREEM ENT AND P UBLIC H EALTH 40 41 (2003), available at http://infojustice.org/download/gcongress/access _to_medicines:_tpp,_acta,_and_eu_border_regulation/baker%20article%204.pdf. 102 Id. at 41. 103 T HE WTO D ECISION ON C OMPULSORY L ICENSING supra note 41 at 50. 104 See Reichman, supra note 16, at 258.

PAGE 87

87 compulsory licenses, and larger market sizes would entice manufacturers in other states to issue compulsory licenses for export. 105 Steps for Collaborativ e Procurement By several Latin American states (such as those in CAFTA DR) negotiating and/or procuring pharmaceuticals together through standardized procedures, they could create a single, larger market with less transaction costs, and producers of gener ic or off pharmaceutical to the entire market at the lowest price. 106 For instance, the nine states of the Organization of Eastern Caribbean States established a common Pharmac eutical Procurement Service (OECS/PPS) in 1986; by 2001, the regional prices that OECS/PPS obtained were typically 44% lower than those obtained by other individual Caribbean states. 107 A centralized procurement authority for a group of Latin American state s could further streamline this process in the future, but even prior to the establishment of such an organization, collective negotiating and standardized attract pharmaceu tical exporters. Steps for Pooled Compulsory Licenses Moreover, the practicable ability to issue pooled compulsory licenses (a compulsory license under which a pharmaceutical product is manufactured in one WTO member state and exported to multiple WTO mem ber states) would augment Latin 105 See i d. 106 Frederick M. Abbott & Jerome H. Reichman, The Doha Round's Public Health Legacy: Strategies for the Production and Diffusion of Patented Medicines under the Amended TRIPS Provisions 10 J I NTL E CON L. 92 1, 973 n.4 (2007) 107 T HE WTO D ECISION ON C OMPULSORY L ICENSING supra note 41 at 59.

PAGE 88

88 Decision 108 (as well as Paragraph 2(a) of the Annex to the TRIPS Agreement in the 2005 Amendment to TRIPS 109 ) delineates that a WTO member may issue a compulsory Member(s) 110 Pooled licenses will incentivize patent holders to offer a discount or voluntary license in order to avoid only states. 111 By numerous states being involved, other more powerful states would be much less likely to apply negative pressure to an entire group of states or implement sanctions against them. 112 If negotiations with the patent holder for a voluntary license o r discount were fruitless, then the process of finding a company in another state to manufacture the product and export it under a compulsory license would be much less difficult because of the larger market size offering more profit opportunities to the e xporting company. 113 Either an organization (such as a procurement service like OECS/PPS or a regional trade agreement body) or representatives of the states could decide together to issue a compulsory license, and then the importing states would do so. 114 How ever, the 108 Implementation of Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health, Decision of 30 August 2002, Doc. WT/L/540 (entered into force Sep. 2, 2003 ) [ hereinafter Paragraph 6 Decision]. 109 TRIPS Amendment, supra note 51 at Annex 2(a). 110 Id. at 2(a). 111 Abbott, supra note 106 at 973 74; T HE WTO D ECISION ON C OMPULSORY L ICENSING supra note 41 at 59. 112 Abbott, supra note 106 at 972 73. 113 Abbott, su pra note 106 at 976; T HE WTO D ECISION ON C OMPULSORY L ICENSING supra note 41 at 61. 114 T HE WTO D ECISION ON C OMPULSORY L ICENSING supra note 41, at 61.

PAGE 89

89 exporting state would only be required to issue one compulsory license for export. 115 Yet the exporter may have to ship the product to each individual state instead of one central location for distribution. 116 Paragraph 3 of the Annex to the Amendmen t to TRIPS among the states in a regional trade agreement in which at least half of the states are least developed states. 117 No grouping of Latin American states (except for Ha iti and any one other state) would meet that requirement. Fostering Conditions for Pooled Compulsory Licenses One of the critical problems with executing this sort of pooled compulsory license recipient(s) of products to be exported under a compulsory license. 118 Encouraging Canada and India 119 to amend their laws and, in particular, advocating for Brazil, with its large and geographically proximate generic manufacturing industr y, to implement a statute permitting Brazil to export products under a compulsory license to other states to issue compulsory licenses. Another positive change would be pressing for a change to the Annex to the Amendment to TRIPS to allow any regional trade agreement (such as one among Latin American states) to establish a Regional Pharmaceutical 115 Id. 116 Id. 117 Tchofou, supra note 64 at 63; T HE WTO D ECISION ON C OMPULSORY L ICENSING supra note 41 a t 60. 118 T HE WTO D ECISION ON C OMPULSORY L ICENSING supra note 41, at 62. 119 Indian legislation ambiguously states that products may be exported under a compulsory license to Id.

PAGE 90

90 Supply Center to which the entire shipment of the product could be shipped and then distributed from, further encouraging exporting companies to produce pharmaceutical products under compulsory licenses for export. Latin American Propensities for Pooled Compulsory Licenses Looking specifically at the Latin American states of CA FTA DR (Costa Rica, Dominican Republic, El Salvador, Guatemala, Honduras, and Nicaragua), the similarities in health indicators in these states will likely underpin shared pharmaceutical needs and opportunities to legitimately issue compulsory licenses col lectively. For instance, asthma is the most common childhood non communicable chronic disease (NCD) among all of these states, 120 and the levels of NCDs among adults (cardiovascular disease, cancers, diabetes, strokes, and respiratory diseases) in these stat es are also rising rapidly 121 This increase is partially a consequence of increased sugar and processed food intake, insufficient exercise, smoking, and alcohol consumption. 122 High income states have begun initiating a variety of prevention programs to curta il the rise in NCDs among those states, but middle income states in 120 Training in Environmental health to Reduce Chronic Diseases in Latin America M OUNT S INAI S CHOOL OF M EDICINE (2012), www.mssm.edu/research/programs/mount sinai global health/education/reducing chronic diseases. 121 N ON C OMMUNICABLE C HRONIC D ISEASES I N L ATIN A MERICA AND THE C ARIBBEAN 7 (Bloomberg School of Public Health & USAID 2009), available at http://www.healthycaribbean.org/publications/documents/NCD in LAC USA ID. developed countries attempted to limit the scope of the Doha Declara tion to the HIV/AIDS crisis, the adopted text reflects the concerns of developing countries and LDCs about the implications of the TRIPS Agreement with regard to public health in general, without limitation to certain diseases. The reference to some specif developing as well as developed countries, such as asthma or cance C ARLOS M. C ORREA I MPLICATIONS OF THE D OHA D ECLARATION ON THE TRIP S A GREEMENT AND P UBLIC H EALTH : H EALTH E CONOMICS AND D RUG S ERIES EDM N O 12 at 5 (2002), http://apps.who.int/medicinedocs/pdf/s2301e/s2301e.pdf ; WHO M ODEL L IST OF E SSENTIAL M EDICINES 26, 31 (2011), http://whqlibdoc.who.int/hq/2011/a95053_eng.pdf. 122 Id.

PAGE 91

91 Central America do not have comparable resources to direct towards such prevention programs and treatments. 123 This accelerating increase in NCDs is extremely concerning to the future socioe conomic development of the CAFTA DR region, as the ability of those without treatment to work will be curtailed, and inequalities may be exacerbated if only those who are wealthy are able to practicably access treatment. 124 Of particular concern are rapid es calations in the incidences of diabetes and more than double the economic cost of HIV/AIDS in the LAC [Latin American and Caribbean] region, and the cost of cardiovascular 125 Consequently, compulsory licenses may be a critical tool in ensuring that these companies are able to procure and sell the treatments at afforda ble prices to all. Other noteworthy statistics among these states include the stabilization of HIV incidence rates 126 but increases in the incidence of cervical cancer 127 Aside from Costa Rica, which has lower levels, these states have similar incidence leve ls of tuberculosis and AIDS (6.6 persons per 100,000 on average), infant and maternal mortality rates, 123 Id. at 7 8. 124 Fernando G De Maio, Understanding chronic non communicable diseases in Latin America: towards an equity based research agenda 7 G LOBALIZATION & H EALTH 1, 3 (2009), availab le at http://www.globalizationandhealth.com/content/pdf/1744 8603 7 36.pdf. 125 N ON C OMMUNICABLE C HRONIC D ISEASES I N L ATIN A MERICA supra note 121 at 7. 126 T OGETHER W E W ILL E ND AIDS 28 (UNAIDS 2012), available at http://www.unaids.org/en/media/unaids/conte ntassets/documents/epidemiology/2012/JC2296_UNAIDS_T ogetherReport_2012_en.pdf. 127 Cervical Cancer and Latin America, an story of inequality G LOBAL /L ATAM H EALTH AND P HARMA (2011), http://rgenneroriganti.wordpress.com/2011/05/10/cervical cancer and latin ame rica an story of inequality/.

PAGE 92

92 and morality rates for diabetes mellitus; aside from Guatemala which has lower rates, these states also have similar mortality rates for ischemic heart d iseases and cerebrovascular diseases (strokes caused by loss of blood flow to the brain, most commonly due to hypertension). 128 Another crucial health concern shared by these states is chagas: a parasitic infection transmitted by the reduviid insect that ini tially presents with flu like symptoms but may remain dormant for decades before reasserting itself with difficult to treat intestinal and cardiovascular issues in nearly a third of those with the disease. 129 Section 4: Future Changes Going forward, due to the smaller populations of many Latin American states and a lack of the conditions necessary for a viable domestic pharmaceutical manufacturing industry, pooled compulsory licenses to import pharmaceutical products offer the most promising strategy for sm aller Latin American states to execute compulsory licenses. For this to come to fruition, the first set of steps involves statutory changes. All Latin any of the perm issible grounds delineated in TRIPS and these states should work with NGOs and other low and middle income states to advocate for states with strong pharmaceutical manufacturing industries to adopt laws allowing for compulsory licenses to be issued for e xport of a product to one or more state (s) based on any of the grounds in TRIPS 128 H EALTH S ITUATION IN THE A MERICAS : B ASIC I NDICATORS 7 9 (Pan American Health Organization 2011), available at ais.paho.org/chi/brochures/2011/BI_2011_ENG.pdf. 129 Carlos Ponce, Current situation of Chagas disease in Central Am erica 102 R IO DE J ANEIRO 41, 41 44 (Suppl. I 2007); Sapna Parikh, Chagas disease most important infection never heard about ABC (May 31, 2012), http://abclocal.go.com/wabc/story?section=news/health&id=8684001.

PAGE 93

93 To bolster their credibility, Latin American states should take care to frame the issue as one involving human rights, restrict the licenses to products that serve a true p ublic health need, attempt to negotiate with the patent holder for a voluntary license (when time permits), and implement protections to ensure that products imported under of the exporting state to label the products also curtails this risk). By collectively executing such steps, there is no evidence that FDI would decrease, and negative consequences from other states are much less likely. In conclusion, collective negoti bargaining power with generic producers through creating a larger market and also with patent holders since they would know that a group of states would be much more likely to attract a foreign pharmaceutical comp any to export the product under a compulsory license. The similar health indicators and issues among certain groups of Latin American states (such as those in CAFTA DR) espouse the existence and future existence of the same permissible grounds for issuing compulsory licenses for products that address true public health concerns among those states. By amending CAFTA DR TRIPS advocating for statutory changes regardin g compulsory licenses for import and export, and developing methods for issuing pooled licenses, practicable access to the right to health through affordable and available access to medicine could be bolstered for countless numbers of Latin Americans.

PAGE 94

94 C HAPTER 4: THE RULES OF FREE TRADE AND ACCESS TO NUTRITION Article 12.1 of the Internati onal Covenant on Economic, Social, and Cultural Rights (ICESCR), 1 also encompasses a broad span of socioeconomic factors which underpin essential conditions for persons to be able to lead healthy lives. 2 To further define these conditions, the United Nati ons Committee on Economic, Social, and Cultural Rights (ICESCR Committee) delineated in General Comment 14(4) that the right to 3 To achieve full realization of the right to health, ICESCR state parties are bound to respect, protect, and proactively fulfill this right by taking specific and continuous steps adequate supply of food 4 This aspect of the right to health also 5 The ICESCR Committee rough the compulsory adoption of national strategies by ICESCR state 1 International Covenant for Economic, Socia l, and Cultural Rights art. 12(1), Dec. 16, 1966, 993 U.N.T.S. 3 [ hereinafter ICESCR]. 2 U.N. Econ. & Soc. Council, Comm. on Econ., Soc. and Cultural Rights, General Comment No. 14( 4 ): The Right to the Highest Attainable Standard of Health, U.N. Doc. E/C. 12/2000/4 (Aug. 11, 2000) [ hereinafter ICESCR General Comment 14]. 3 Id. 4 Id. at 14(15, 36). 5 ICESCR, supra note 1 at Art. 11(1).

PAGE 95

95 6 State parties are called to use their available resources in cost efficient manners in order to progressively ensure access to nutritionally adequate food. 7 In fact, like providing those medicines defined by 8 O nutritionally deficient. 9 Children and pregnant women are the most susceptible to these deficiencies, and even if a person merely suffers from a moderate deficiency, there will still likely be serious, long te rm consequences on his or her physical health and mental development. 10 These outcomes will also have a significant impact at the macro level through the loss of human capital formation, economic productivity, and rising public health costs since micronutri ent deficiencies account for 7.3% of global disease incidence. 11 In Latin America, nine million children (under the age of five) are malnourished. 12 While the human cost of child malnutrition (physical and mental damage) has been well 6 U.N. Econ. & Soc. Council, Comm. on Econ., Soc. and Cultural Rights, General Comment No. 12(1, 21): The Right to Adequ ate Food, U.N. Doc. E/C.12/1999/5 (May 12, 1999) [ hereinafter ICESCR General Comment 12]. 7 Id. at ICESCR General Comment 12(14). 8 ICESCR General Comment 14, supra note 2 at 14(43(b),(d)). 9 L INDSAY A LLAN B RUNO DE B ENOIST O MAR D ARY & R ICHARD H URRELL ( eds.), G UIDELINES ON F OOD F ORTIFICATION WITH M ICRONUTRIENTS : WHO AND F OOD AND A GRICULTURAL O RGANIZATION OF THE U NITED N ATIONS 3 (2006), available at http://www.who.int/nutrition/publications/guide_food_fortification_micronutrients.pdf. 10 Id. 11 Id. 12 Malnut rition costs Latin America billions of dollars per year A LERT N ET (Oct. 15, 2009), http://www.trust.org/alertnet/news/malnutrition costs latin america billions of dollars per year/.

PAGE 96

96 documented, the econom nearly half of children suffer from chronic malnutrition, U.N. estimates put the cost at $3.1 billion (USD) a 13 Persons worldwide frequently suffer fro m deficiencies in zinc, folate, vitamin B12 and other B vitamins, vitamin C, vitamin D, calcium, and fluoride, but the three most common forms of micronutrient malnutrition are iodine, iron, and Vitamin A deficiencies. 14 In developing states, iodine deficie 15 Additionally, among those same states, cognitive function, school p 16 Regarding iodine, there is a moderate r isk of iodine deficiency among school age children in the DR and Haiti. 17 Turning to iron, the prevalence of anemia among preschool children is severe (over 40%) in Brazil, Bolivia, Peru, Mexico, and the CAFTA region (except Nicaragua and the Dominican Re public (DR)). 18 Regarding Vitamin A, among preschool children, Vitamin A deficiencies remain a severe public health concern 13 Id. 14 A LLAN supra note 9 at 3. 15 Id. at 5. 16 Id. at 5, 51. 17 Degree of public health significance of iodine nutrition based on median urinary iodine: 1993 2006 WHO (2008), http://www. who.int/vmnis/iodine/status/summary/median_ui_2007_color.pdf. 18 Anemia as a Public Health Problem by Country, Pre school Age Children WHO (2008), http://www.who.int/vmnis/anaemia/prevalence/summary/Pre SAC_anaemia.pdf.

PAGE 97

97 in Bolivia and Mexico and a moderate concern in El Salvador, Guatemala, Honduras, Ecuador, Brazil, Peru, Argentina, Uruguay, and Para guay. 19 In the Americas as a whole, 10% of the population has insufficient iodine, 19% is anemic, and 20% of preschool children are Vitamin A deficient. 20 One of the cost efficient means for achieving the realization of and access to a sufficient nutritional more essential nutrients to a food whether or not it is normally contained in the food for the purpose of preventing or correcting a demonstrated deficiency of one or more nutrients in 21 This Chapter will posit that measures which are implemented to promote fortified foods but in doing so, may limit international trade fall under the purview of and do not necessarily violate the relevant trade rules found in the SPS Agreement which addresses the application of food safety and animal/plant health regulations. However, if it is determined that measures to promote fortified foods do not fall under the purview of the SPS Agreement, then they would be subject to the TBT Agreement) and, like with the SPS Agreement, could be properly tailored in order to comply with the TBT Agreement. Section 1 examines the facets of food fortification, and Section 2 follows with an analysis of the legality unde r the General Agreement on Tariffs and Trade of measures to promote fortified foods but may limit international trade as a result. Sections 3 and 4 19 Countries and areas with survey data and regression based estimates: Preschool age children WHO (2008), http://www.who.int/vmnis/vitamina/prevalence/vita_fig2b.pdf. 20 A LL AN supra note 9 at 4. 21 Codex General Principles for the Addition of Essential Nutrients to Food 2.5, CAC/GL 09 1987 (amended 1989, 1991).

PAGE 98

98 evaluate the legality of these measures under the SPS Agreement and the TBT Agreement respectively. Sectio n 1: Fortification One of the most successful ways for combating malnutrition is through fortification. The results of past fortification programs have demonstrated high benefit to cost ratios and that fortification is a more cost effective way of achievin g the same public outcomes than other strategies such as nutritional education, encouragement of doses of micronutrients, usually in the form of pills, capsules or syrup term effect on access to nutrition. 22 Frequent and regular consumption of fortified foods allows a body to develop body stores of nutrients more efficiently and more effectively than it would be able to throug h intermittent supplements. 23 Additionally, fortification generally aims to supply micronutrients in quantities that approximate those provided by a well balanced diet, does not necessitate changes in public eating patterns, can be transported through exist ing delivery systems, and typically does not significantly increase the marginal cost of production. 24 Possible disadvantages include initial fixed costs for fortification technology, lack of access of the poorest sectors of the population to the food produ ct chosen to be fortified, and changes in food taste or consistency after fortification. 25 However, as Latin American economies are developing and the middle class is 22 Id. at 11 13, 207 8, 210. 23 Id. at 20. 24 Id. at 21. 25 Id. at 23.

PAGE 99

99 burgeoning, 26 it is increasingly feasible for governments to support investment in fortific ation and for greater numbers of people to have practicable access to fortified fortification are advancing 27 Fortification has a long history in developed states, beginning with salt iodization in the U.S. in the 1920s. 28 Since the 1940s, cereal products have been fortified with various micronutrients, and milk has been fortified with Vitamin D. 29 Recently across the Americas, wheat fortification with folic acid has become increasingly widespread. 30 These examples have been particularly effective given how widely and regularly those food products are consumed. 31 Fortification at the national level may be voluntary or mandatory (producers are legally compelled to fortify specific food products with certain levels of micronutrients). Mandatory fortification is comparatively better suited for widespread nutritional deficiencies under the following conditions: either the industry which produces the food product is relativel y centralized and well organized or, if there are numerous, small producers, there is a collective agreement such as an industry association in place; nutritional knowledge is relatively low or the public does not exhibit a significant preference for volun tarily fortified foods; and the public will accept 26 D E MOCRACY D IGEST (August 14, 2012), http://www.demdigest.net/blog/2012/08/latin americas inclusive middle class/. 27 A LLAN supra note 9 at 23. 28 A LLAN supra note 9 at 14. 29 Id. 30 Id. 31 Id.

PAGE 100

100 governmental actions in this area. 32 If a state chooses to implement mandatory or voluntary fortification of a food product, the objectives of that fortification could be undermined by lower priced imports of that same food product but non fortified. Therefore, the question becomes under the rules of free trade: can a state limit imports (through tariffs or a complete ban) of a non fortified food product if that same product is mandatorily or voluntarily for tified by domestic producers? Section 2: GATT The rules of free trade are delineated in several dozen binding WTO agreements, including the initial General Agreement on Tariffs and Trade (GATT), 33 the SPS Agreement, and the TBT Agreement. According to Artic le III(2) of GATT, WTO member states are bound to treat imported products from other WTO member states in a manner identical to that of like domestic products (no additional direct or indirect taxes or internal charges and accorded no less favorable treatm ent with respect to laws, 34 The following are the four general criteria for ysical attributes of the products, the tariff classifications. 35 Further information to more fully define these criteria is found in European Communities Measures Affect ing Asbestos and Asbestos Containing 32 Id. at 35 37. 33 General Agreement on Tariffs and Trade 1994, Apr. 15, 1994, Marrakesh Agreement Establishing the World Trade Organization, 33 I.L.M. 1153 (1994) [ hereinafter GATT]. 34 Id. at Art. III(2, 4). 35 B ERTA E SPERANZA H ERNNDEZ T RUYOL & S TEPHEN J. P OWELL J UST T RADE : A N EW C OVENANT L INKING T RADE AND H UMAN R IGH TS 34 (2009).

PAGE 101

101 Products 36 health grounds, as asbestos is a known carcinogen, and the subsequent challenge of the ban by Canada as product discrimination against GATT Article III(4). 37 The initial EC Asbestos panel determined that asbestos products and asbestos free substitutes their end uses were often equivalent. 38 However, determinations, the WTO Appellate Body reached the opposite conclusion by reasoning that, given toxicity properties of the product, and it considerably affe cted consumer expectations. 39 Therefore, the two were not like products, and there was no product discrimination. 40 Looking at fortified and non fortified versions of the same food product (such as wheat and wheat fortified with Vitamin A), both would large ly share the same physical characteristics (but there would be differences on the chemical composition level), identical end uses, and similar consumer expectations. Consumers are typically unaware of which food products are fortified and the benefits of t hat fortification and thus would be unlikely to make decisions based on the value added of that fortification. The increases in health benefits from fortified wheat (or conversely the opportunity cost of lost health benefits through consumption of non fort ified wheat) likely do not meet the 36 European Communities Measures Affecting Asbestos and Asbestos Containing Products, WT/DS135/AB/R (12 March 2001) [ hereinafter EC Asbestos]. 37 H ERNNDEZ T RUYOL supra note 35, at at 33. 38 Id. 39 Id. 40 Id.

PAGE 102

102 EC Asbestos decision. Therefore, a tax or ban on imports of a non fortified food product would likely violate GATT. es are not applied in a manner which would constitute a means of arbitrary or unjustifiable discrimination between countries where the same conditions prevail, or a disguised restriction on o protect human 41 To meet this exception, a measure necessary for the achievement of the objectives of that measure. 42 essity U.S. Restrictions on Imports of Tuna II 43 which held that, to meet the Public Health exception, the measure to be implemented must be the least GATT inconsistent of those measures which are reasonably available i n order to achieve the same objective. 44 The WTO Appellate Body further weakened the test in EC Asbestos which is less GATT 45 These factors include the expected effectiveness of the measure to achieve the proffered objective, the significance of that objective, and the expected impact of the measure on 41 GATT, supra note 33 at Art. XX (b). 42 H ERNNDEZ T RUYOL supra note 35 at 96. 43 U.S. Restrictions on Imports of Tuna II, DS29/R (16 June 1994). 44 H ERNNDEZ T RUYOL supra note 35 at 97. 45 Id. at 98.

PAGE 103

103 international trade. 46 If this analysis results in a preliminary conclusion that the measure is indeed necessary, then this determination must be confirmed by comparing the inconsistent alternative measures: the likelihood that the implementation of those alternatives would achieve t he same gains toward the objective and the severity of the consequences of that failure. 47 In the Brazil Measures Affecting Imports of Retreaded Tyres case, the WTO pr 48 The WTO Appellate Body also concluded that the proposed alternative measures were mostly remedial (waste management and disposal) and thus were not t rue alternatives to the import ban, which could thwart the accumulation of these tyres. 49 Similarly, in EC Asbestos the WTO Appellate Body established that that the obj ective of the measure saving human lives 50 The more significant and vital the pursued objective is, the lower the 51 46 WTO rules and environmental policies: GATT exception WTO (2012), http://www.wto.or g/english/tratop_e/envir_e/envt_rules_exceptions_e.htm. 47 Id. ; H ERNNDEZ T RUYOL supra note 35 at 98. 48 WTO rules and environmental policies: GATT exception supra note 46 49 Id. 50 Id. 51 Id.

PAGE 104

104 Regarding fortified and non f ortified food products, it is foreseeable that many (if not all) instances of tariffs or bans on non for necessity. While malnutrition does have detrimental effects on health, malnutrition does not have the same significant and direct relationship with fatalities as asbestos in EC Asbestos did. The aim of fortified foods is not to protect populations from characteristics of a that food product, and the levels of malnutrition which are hoped to be corrected will all affect the effectiveness of a measure to tax or ban non fortified imported food products and the impact on international trade. However, it is very possible that even if the measure is preliminarily found to be necessary, it could fail a balancing test with the alternative of labeling non fortified foods. However, there are many factors which could l imit the effectiveness of the labeling, including higher prices, low customer demand, and low supply of fortified foods. While labeling could be paired with consumer education to increase effectiveness, price elasticity will likely remain extremely high be tween fortified and non fortified products and limit the effectiveness of labeling as an alternative. Section 3: SPS Agreement However, meeting the GATT Article XX(b) exception is not necessary if measures to promote fortified foods fall under the purview of the SPS Agreement. The SPS Agreement applies to all sanitary and phytosanitary measures which may, directly

PAGE 105

105 or indirectly, have an impact on international trade. 52 e enacted to: (a)protect animal or plant life or health within the territory of the Member from risks arising from the entry, establishment or spread of pests, diseases, disease carrying organisms or disease causing organisms; (b) to protect human or anima l life or health within the territory of the Member from risks arising from additives, contaminants, toxins or disease causing organisms in foods, beverages or feedstuffs; (c) to protect human life or health within the territory of the Member from risks a rising from diseases carried by animals, plants or products thereof, or from the entry, establishment or spread of pests; or (d) to prevent or limit other damage within the territory of the Member from the entry, establishment or spread of pests. 53 WTO Mem bers are bound to ensure that their sanitary and phytosanitary measures neither arbitrarily nor unjustifiably discriminate among WTO Members where identical or comparable conditions are present, including between their own territory and territories of othe r WTO Members; additionally, WTO Members must not apply these 54 Measures which conform to the SPS Agreement are also presumed to meet the prerequisites for the Pu blic Health Exception in GATT Article XX(b); however, the converse is not true. 55 Therefore, if measures to promote fortified foods are determined to be both covered by and in compliance with the SPS Agreement, then they are in compliance with the GATT Publ ic Health exception. Yet, if such measures are found to 52 Agreement on the Application of Sanitary and Phytosanitary Mea sures, GATT Doc. MTN/FA II A1A 4 (Dec. 15, 1993) (entered into force January 1, 1995), available at http://www.wto.org/english/tratop_e/sps_e/spsagr_e.htm#fnt5 [ hereinafter SPS Agreement]. 53 Id. at Annex A(1). 54 Id. at Art. 2(3). 55 H ERNNDEZ T RUYOL supra note 35 at 118.

PAGE 106

106 be covered but inconsistent with the SPS Agreement, then states cannot claim protection for such measures under the GATT Public Health exception. SPS Agreement Annex 1(A)(b) delineates that that Agre ement applies to laws and regulations which are enacted to protect human health from risks arising from itself and not normally used as a typical ingredient of the food, w hether or not it has 56 Micronutrients which are added to food products are a type of additive 57 Therefore, since a measure that was enacted for the purpose of protecting human health from risks arising from additives in a food product (suc h as the addition of micronutrients to a food product) would clearly be a sanitary measure, one could also risks of not adding them. When one evaluates the risks of a p articular decision, implicit in that analysis are the risks of not making a particular decision; conversely, when evaluating the benefits of a particular action, the opportunity cost of any foregone benefits from the alternative decision is implicitly take n into account. For instance, when evaluating the risks of a particular diagnostic test such as a mammogram or prostate exam, the risks arising from the exam which must be taken into account include the tant costs of unnecessary treatment and emotional turmoil. Hence, the risks relating to or stemming from micronutrients encompass the risks of not adding micronutrients to certain foods, and any law or 56 Codex General Principles for Food Additives 2(a), CODEX STAN 192 1995 (1995, amended 2012). 57 See Commission of the European Communities v. French Republic, C 24/00 (5 Feb. 2004); Commission of the European Communities v Kingdom of Den mark, C 467/98 (5 Nov. 2002).

PAGE 107

107 regulation enacted to protect human health from an ide ntified risk of a particular type of General Principles for the Addition of Essential Nutrients to Food tosanitary measures which conform to international standards, guidelines or recommendations shall be deemed to be necessary to protect human, animal or plant life or health, and presumed to be consistent with the relevant provisions of this Agreement and o f GATT and recommendations established by the Codex Alimentarius Commission [CAC] relat ing to food additives, veterinary drug and pesticide residues, contaminants, pertinent. (The CAC, established by the Food and Agriculture Organization of the UN and WHO in 1963, produces harmonized international standards and codes relating to food in order to safeguard consumer health and fair trade practices.) 58 The SPS explicitly defined, a nd therefore, any CAC text could form the basis of a justification for a sanitary measure under the SPS Agreement, but the substantive content, as opposed to the category of the text, would determine, on a case by case basis, if that text established a suf ficient foundation for justification. 59 Therefore, any sanitary measures 58 About Codex, C ODEX A LIMENTARIUS C OMMISSION I NTERNATIONAL F OOD S TANDARDS (2012), http://www.codexalimentarius.org/about codex/en/. 59 Joint FAO/WHO Food Standards Programme: Codex Alimentarius Commission, 23d Sess., Report of the Forty fifth Sess. of the Exec. Comm. of the Codex Alimentarius Commission, ALINORM 99/33, June 5, 1998 [ hereinafter 1998 CAC Executive Committee Session].

PAGE 108

108 taken to conform to CAC texts, providing that the text encompasses ample substantive content related to that sanitary measure, are deemed as appropriate, necessary, and consistent with the SPS Agreement. General Principles for the Addition of Essential Nutrients to Food 60 responsible for developing guidelines and legal texts pertaining to the addition of essential nutrients to foods establish a uniform set of principles for the rational addition of essential nutrients [and] maintain or improve the overall nutritional quality 61 Paragraph 6.1 describes that food for tification is the purview of national authorities, as the types and quantities of essential nutrients to be added and foods to characteristics of the target populations, and the food consumption patterns of the by the population at risk, [t]he intake of the food selected as a vehicle should be stable and uniform and the lower and upper levels of intake should be known [and] [t]he amount of the essential nutrient added to the food should be sufficient to correct or prevent the deficiency when the food is consumed in normal amounts by the population 62 As a prerequisite for fortifi increasing the intake of an essential nutrient in one or more population groups. This 60 Codex General Principles for the Addition of Essential Nutrients to Food, supra note 2 1 at 2.5. 61 Id. at Introduction. 62 Id. at 6.2.2, 6.2.3, 6.2.4.

PAGE 109

109 may be in the form of actual clinical or subclinical evidence of deficiency, estimations indicating low levels of intake of nutrients or possible deficiencies likely to develop 63 Fortification interventions are then health benefits that may be derived from increased micronutrient intakes .based on thus encompasses the growing range of different types of food fortification initiatives that have been implemented in recent years in response to an increasingly diverse set 64 As an example of what constitutes a demonstrated need, looking at Vitamin A, ducts, eggs, fruits and vegetables), poor nutritional status, and a high rate of infections, in particular, 65 Indicators of Vitamin A deficiency are the prevalence of night blindness presented in clinical examinations am ong children under the age of 6 and pregnant women, as well as retinol levels in the serum or plasma of preschoolers or breast milk of lactating women. 66 For instance, if more than 1% of children under the age of 6 or more than 5% of pregnant women display night blindness during an exam, this is evidence of a mild deficiency in the population as a whole; if more than 5% of these children show night blindness, this is evidence of a severe 63 Id. at 6.2.1. 64 A LLAN supra note 9 at 25. 65 Id. at 51. 66 Id.

PAGE 110

110 deficiency in the population. 67 In Guatemala, nearly 16% of children di splay evidence of Vitamin A deficiency. 68 To analyze the public health benefits of fortification, one common approach is cost effectiveness, which is defined as the cost of achieving a particular outcome. In the might include: averting one case of subclinical vitamin A deficiency, averting one case of anemia, or averting one case of 69 Two frequently employed cost effectiveness measures ability adjusted life 70 The latter encompasses both mortality and morbidity by calculating the cost per year of life saved from early death, ill health, or disability. 71 loss of healthy life, expressed in disability adjusted life years (DALYs), iron deficiency anemia results in 25 million DALYs lost (or 2.4% of the global total), vitamin A deficiency in 18 million DALYs lost (or 1.8% of the global total) and iodine deficiency in 2.5 million DALYs lost (o 72 Cost effectiveness measures are conducive to comparing different types of interventions that share the same objective (for instance, supplementation and fortification) by comparing the unit cost of each to achieve one 67 Id. at 50. 68 Guatemala M ICRONUTRIENT I NITIATIVE http://www.micronutrient.org/english/view.asp?x=620 (last viewed November 23, 2012). 69 A LLAN supra note 23, at 207. 70 Id. at 208. 71 Id. 72 Id. at 3.

PAGE 111

111 DALY sa ved or to avert one death. 73 One could also use cost effectiveness measurements to compare the costs of one particular outcome versus the costs if that outcome is not avoided (for instance the costs of fortification to avoid one case of anemia versus the co sts of not avoiding that case of anemia (medical costs and lost productivity)). However, to properly compare interventions which aim to achieve different goals, then a cost benefit analysis is more appropriate. This type of analysis compares the cost of the intervention to the value of the outcome (the benefit). 74 These benefits could include increased productivity (for instance, iron fortification will lead to less anemic and therefore, more productive adults) and lower health care system costs (anemic mo thers typically incur more complications during childbirth). 75 benefit analyses may be exercised to compare the relative merits of health interventions with other kinds of government spending, they are particularly valuable in advocating for inc reased 76 the financial benefit of a particular health outcome; for example, to analyze the benefits of an iodine fortification intervention one could look to studies that have estimated the costs stemming from the amount of lost productivity per child born to a mother with goitre (caused by iodine deficiency). 77 Benefits can be difficult to quantify as questions 73 Id. at 208. 74 Id. at 210. 75 Id. 76 Id. 77 Id.

PAGE 112

112 arise regarding the rate at w hich to discount future income streams in order to determine their present value, the future costs which are not incurred by public health systems, and the differences in likely future productivity of persons from varying socioeconomic backgrounds. Yet thi s is still a useful measurement for estimating plausible benefits. 78 Estimating unit costs (the annual per capita cost of the intervention) should incorporate initial technological investments, the costs of marketing in order to attain public awareness an d acceptance, quality control, and, for supplements, distribution. 79 Unit costs of fortification vary significantly based upon the food vehicle employed, the initial level of deficiency in the target population, the size of the targeted population, and init ial dietary patterns, 80 30 times higher than fortification costs in the case of iodine, 3 30 times higher for iron, and 1.5 3 times higher for vitamin A. The cost differential is largely dependent on what proportion the t arget population is of the whole population; fortification becomes increasingly cost 81 Therefore, fortification is appropriate where a demonstrable need exists and where it is justified by cost effectiveness and cost benefit analyses. The General Principles for the Addition of Essential Nutrients to Food which aims to establish uniform principles for food fortification, note that it is the purview of the national authoritie 78 Id. at 215. 79 Id. at 210 11. 80 Id. at 214. 81 Id. at 211.

PAGE 113

113 82 Additionally, the food product selected as the vehicle for fortification must be consumed by the target population; in some cases, voluntary fortification programs will be sufficient for promoting the production of fortified products that reach the plates of the targeted consumers. In others, mandatory fortification by foo d products, tariffs or a ban on non fortified food products also may be indispensable competition with cost advantages from free 83 A practical exampl e may be seen in the future as the U.S. Center for Disease Control works with the government of the Dominican Republic to implement a voluntary fortification intervention of sugar with Vitamin A and whether imported non fortified sugar undermines that inte rvention. 84 However, as previous noted, any CAC text can form the basis of a justification for a sanitary measure under the SPS Agreement if the substantive content of the text establishes a sufficient foundation for the justification. 85 Therefore, the fol lowing question must be addressed: whether the General Principles for the Addition of Essential Nutrients to Food provides sufficient substantive content for sanitary measures to be established in conformity with it and thus deemed as necessary, appropriat e and consistent with the SPS Agreement? These principles are not 82 Codex General Principles for the Addition of Essential Nutrients to Food, supra note 2 1 at 6.1. 83 Andreas Blthner & Leonie Vierck Setting Standards for Business and Development How legal Frameworks can support market based Nutrition Partnership 4 E URO F EED & F OOD L. R EV 104, 115 n.2 (2009). 84 See Dominican Republic CD C (February 8, 2011), http://www.cdc.gov/immpact/projects/country/dominicanrepublic.html. 85 1998 CAC Executive Committee Session, supra note 59

PAGE 114

114 supplemented by any international standards for fortified foods other than the Codex Standard for Food Grade Salt 86 deficient areas, food grade salt shall be iodised to prevent iodine deficiency disorders (IDD) for public health 87 No such standards exist for Vitamin A or iron fortification. While an express purpose of the General Pr inciples was to provide uniform standards for fortification, one could argue that there is insufficient substantive content to justify national authorities imposing tariffs based on their ability to establish the types of foods to be fortified and quantifi es of micronutrients added. Risk Assessment If it was determined that the General Principles lacked ample substantive content, then this could be remedied by an amendment to encompass a delineation of the requisite conditions for the proper imposition of s uch tariffs or a broadening of the Codex Standard for Food Grade Salt cannot likely be replicated for other food products because different states will use different food vehicles for diff erent micronutrients. Lacking such an amendment, efforts to limit trade in order to promote fortification would compose a sanitary measure not presumptively in accordance with the SPS Agreement via compliance with a CAC standard. Therefore, to not violate the SPS Agreement, any animal or plant life or health, [be] based on scientific principles and not [be] 86 Codex Standard for Food Grade Salt, CX Stan 150 1985 (revised 1997, amended 1999, 2001). 87 Id. at 3.4, 9 .3.

PAGE 115

115 88 Additionall y, such a measure would to human, animal or plant life or health, taking into account risk assessment techniques 89 When assessing the risk to available relevant scientific evidence, economic factor trade restrictive than required to achieve their appropriate l evel of sanitary or 90 In European Communities EC Measures Concerning Meat and Meat Products (EC Hormones) 91 the WTO Appellate Body highlighted that even where domestic and imported products are treated alike, regulations may still be found to be unjustifiably trade restrictive without specific scientific justification for their necessity and the performance of a risk assessment. 92 In that case, the European Communities had b anned the importation of meat or meat products from cattle which had received one of 88 SPS Agreement, supra note 5 2, at Art. 2(2). 89 Id. at 5(1). 90 Id. at Art. 5(2 4,6). 91 European Communities EC Measures Concerning Meat and Meat Products AB 1997 4 Report of the Appellate Body, WT/DS26/AB/R, WT/DS48/AB/R (Jan.16, 1998) [ hereina fter EC Hormones] 92 See id at 177.

PAGE 116

116 six growth hormones alleged to be possibly carcinogenic. 93 The Appellate Body concluded that the scientific evidence taken into account by the European Communities in its and opinions of individual scientists submitted by the European Communities constitute general studies which do indeed show the existence of a general risk of cancer; bu t they do not focus on and do not address the particular kind of risk here at stake the carcinogenic or genotoxic potential of the residues of those hormones found in meat derived from cattle to which the hormones had been administered for growth promoti on 94 Without providing an evaluation of the precise, potentially negative effects of not imposing the ban, the Appellate Body held that the European Communities did not execute a risk assessment in accordance with SPS Agreement Article 5, and con sequently, the import ban lacked proper justification and thus violated the SPS Agreement. Applying this holding to the issue of fortified foods, justifiying a tariff or ban on imports of non fortified foods would entail sufficient scientific evidence and the performance of a risk assessment. This assessment would likely require specific evidence regarding differences in nutritional levels of persons who consume a particular fortified food product versus a non fects of and the effect of a lower priced non fortified food product on purch ases of the fortified 93 Id. at 2, 29. 94 Id. at 200.

PAGE 117

117 food product. Attaining such evidence may require continued allowance of non fortified are not more trade restrictive than required to achieve their appropriate level of sanitary fortified food products may be the appropriate measure under the SPS Agreement, as opposed to an import ban. The likelihood of tariffs succee ding in promoting a fortified food product would, in all likelihood, improve if coupled with laws that encouraged or compelled suppliers and retailers to offer the fortified version if they sell the non fortified version and promote the fortified product m ore strongly. Section 4: TBT Agreement However, if it is determined that measures to promote fortified foods do not fall under the purview of the SPS Agreement, then such measures would be subject to TBT Agreement. 95 include or deal exclusively with terminology, symbols, packaging, marking or labelling requirements as they apply to a product, process sanitary or phytosanitary measures. 96 Analogous to the SPS Agreement, WTO Members must make certain that, regarding technical regulations, products imported from another WTO Member receive equally favorable treatment as like domestically 95 Agreement on Technical Barriers to Trade, Apr. 15, 1994, Marrakesh Agreement Establishing the World Trade Organization, Annex 1A, Legal Instruments -Results of the Uruguay Round, 1868 U.NT.S. 120 (entered into force January 1, 1995), available at http:// www.wto.org/english/docs_e/legal_e/17 tbt_e. htm [ hereinafter TBT Agreement]. 96 Id. at Art. 1.5, Annex 1(1).

PAGE 118

118 produced products or like products imported from any other state. 97 Additionally, 98 Fu rthermore, WTO restricti ve than necessary to fulfil a l 99 WTO Members are compelled to take into account the risks of not fulfilling that objective, and inter alia: av ailable scientific and technical information, related processing technology or intended end 100 Where a technical regulation is put into place to fulfill a legitimate objective, there is a rebuttable presumption that it does not compose an unnecessary obstacle to trade. 101 relevant international standards exist or their completion is imminent, Members shall use them, or the relevant parts of them, as a basis for 102 and repeated use, rules, guidelines or characteristics for products or related processes 97 Id. at Art. 2.1. 98 Id. at Art. 2.8. 99 Id. at Art. 2.2. 100 Id. 101 R OS E N ATHAN F OOD F ORTIFICA TION R EGULATION I N L IGHT OF THE WTO A GREEMENTS 5 (2012), available at http://ebookbrowse.com/wto and food fortification regulation rn english pdf d287639547. 102 TBT Agreement, supra note 13, at Art. 2.4.

PAGE 119

119 and production methods, with which compliance is not m 103 Similarly to the General Principles for the Addition of Essential Nutrients to Food 104 However, there is a notable distinction in that there is no express requirement that the standards provide sufficient substantive content to form the basis for the regulation. Therefore, it seems very likely that the General Principles which calls for fortification to be the purview of national authorities 105 could form the basis for regulations relating to for tified food products such as labeling, food types suitable for fortification, and voluntary or mandatory minimum levels of fortification in those food types. In another notable difference from the SPS Agreement, the TBT Agreement does not compel a WTO me mber to base its technical regulations on the results of a risk assessment of scientific evidence and economic factors but instead merely consider the risks of not fulfilling the objective of the regulation, taking into account scientific information. This establishes a much easier burden of proof to reach than that of the SPS Agreement and would necessitate much less precise information regarding differences in nutritional levels of persons who consume a particular fortified food 103 Id. at Annex 1(2). 104 L EONI E V IERCK F OOD F ORTIFICATION : GTZ/SAFO S TANDARD S ETTING T OOL FOR N ATIONAL F OOD F ORTIFICATION P ROGRAMMES E SPECIALLY IN D EVELOPING C OUNTRIES 13 (Oct. 27, 2009), http://food fortification.com/Files/Download/Resources/gtz en safo standard setting tool 2009.pdf 105 Codex General Principles for the Addition of Essential Nutrients to Food, supra note 2 1 at 6.1, 6.2.1.

PAGE 120

120 product versus a non forti and elasticity of demand for fortified foods. Instead, fulfilling the prerequisites of the General Pri nciples nutrient in one or more population groups [which] may be in the form of actual clinical or subclinical evidence of deficiency, estimates indicating low levels of intake of nutrie nts or possible deficiencies likely to develop because of changes taking place in 106 ) will likely provide the necessary scientific information. Therefore, it is highly probable that technical regulations which support fortification will meet the requirements of the TBT Agreement if they are in accordance with the factors delineated in the General Principles for the Addition of Essential Nutrients to Food A rebuttable presumption will then exist that these measures will not form unnecessary obsta cles to trade, but depending on the particular case, mandatory bans or high tariffs may be found to be unnecessary in light of evidence regarding the effectiveness of consumer education, the benefits of fortification and labeling, and of demand. Yet, with sufficiently strong evidence of the need to ban imports of a non fortified food product, the measure would be valid. In conclusion, a s micro nutritional deficiencies persist in Latin America, fortification technology improves, and L atin American economies continually strengthen, it is foreseeable that fortification will become an increasingly effective tactic for Latin American states to progressively realize the right to health. If circumstances warrant mandatory domestic fortificat ion and the imposition of tariffs or bans on imports which 106 Id. at 6.2.1.

PAGE 121

121 are challenged by another WTO Member State under either the SPS Agreement or TBT Agreement then this Chapter will provide a framework for effectively rebutting that legal challenge

PAGE 122

122 CHAPTER 5 U. S. LATIN AMERICAN FREE TRADE AGREEMENTS AND HEALTHY WORKING CONDITIONS another fundamental determinant of health and are thus embraced as an additional key component of the right t o health. 1 ICESCR Article 12(2)(c) specifically dictates that the g the requisite steps for state parties to take in order to achieve full realization of the right to health. 2 respect of occupational accidents and diseases 3 the prevention and reduction of the populatio n's exposure to harmful substances such as radiation and harmful chemicals or other detrimental environmental conditions that directly or indirectly impact upon human health the minimization, so far as is reasonably practicable, of the causes of heal th hazards inherent in the working environment [and] safe and hygienic working 4 1 U.N. Econ. & Soc. Council, Comm. on Econ., Soc. and Cultural Rights, General Comment No. 14( 4 ): The Right to the Highest Attai nable Standard of Health, U.N. Doc. E/C. 12/2000/4 (Aug. 11, 2000) [ hereinafter ICESCR General Comment 14]. 2 International Covenant for Economic, Social, and Cultural Rights art. 12( 2 ) (c) Dec. 16, 1966, 993 U.N.T.S. 3 [ hereinafter ICESCR]. 3 tional accident covers an occurrence arising out of, or in the course of, work which results in fatal or non fatal injury an occupational disease covers any disease contracted as a result of an O, P155 Protocol of 2002 to the Occupational Safety and Health Convention art. 1(a b), 1981, available at http://www.ilo.org/dyn/normlex/en/f?p=NORMLEXPUB:55:0:::55:P55_TYPE,P55_LANG,P55_DOCUMEN T,P55_NODE:SUP,en,P155,/Document [ hereinafter Protocol of 20 02]. 4 ICESCR General Comment 14, supra note 1 at 14(15).

PAGE 123

123 Millions of persons are exposed to physical, chemical, biological, and psychosocial hazards in their workplace environments. 5 Physical hazards encompass unr easonably arduous physical workloads and ergonomically deficient working conditions which may result in injuries or musculoskeletal disorders. 6 Other physical ionizing radiation, heat and other unhealthy microclimatic conditions that can adversely affect health 7 Regarding chemical hazards, over three hundred chemicals commonly used in workplaces around the world have been identified as carcinogens. 8 On a psychosocial level, working in a stressful work e nvironment is strongly correlated with an increased incidence of cardiovascular diseases (such as hypertension) and mental disorders. 9 Looking at Latin America specifically, millions of Latin Americans are subject to the risk of exposure to hazards in the workplace 10 as their governments fail to workers are regularly fired for removing themselves from dangerous conditions in the workplace, and e nforcement of occupational s afety and health law is lax. 11 5 A NTONIO G IUFFRIDA R OBERT F. I UNES & W ILLIAM D. S AVEOFF E CONOMIC AND H EALTH E FFECTS OF O CCUPATIONAL H AZARDS IN L ATIN A MERICA AND THE C ARIBBEAN 3 (Inter American Development Bank 2001), availab le at http://idbdocs.iadb.org/wsdocs/getdocument.aspx?docnum=353816. 6 Id. 7 Id. 8 Id. at 3. 9 Id. at 4. 10 Id. at 3. 11 CAFTA L ABOR R IGHTS R EPORT C OSTA R ICA D OMINICAN R EPUBLIC E L S ALVADOR G UATEMALA H ONDURAS AND N ICARAGUA 94 (June 2005), available a t http://www.dol.gov/ilab/media/reports/usfta/DRLaborRights.pdf.

PAGE 124

124 are not always sanctioned for safety and health violations, and labor inspectors often fail to investigate industrial accidents fully or to assign responsibility for negligence. Historically, the corps of labor insp ectors has suffered from inadequate resources, 12 In 2003, Nicaragua had less than one hundred labor inspectors for the entire country, and those inspectors rarely issued monetary penalties for labor viola tions. 13 The garment industry is a particularly workers in the garment industry complained of respiratory problems, skin allergies, back aches and muscular pains caused from repetitive motion, and psychological stress caused by working long hours under pressure to meet high quotas. Fifty two percent of the workers found that the heat levels in the factories were intolerable. Seventy one percent of the workers interviewed had never received any instructions about fire safety, and sixty three percent were not aware of any evacuation procedure in case of fire. 14 In 2003, El Salvador only had sixty Human Rights Watch, inspectors in El Salvador conduct inspections but fail to issue findings or impose sanctions and may improperly apply the law. Human Rights Watch has also alleged that inspectors fail to interview workers and base their findings solely on employer testimony and compa 15 In the Dominican Republic (DR), a 12 Id. 13 Id. at 140. 14 Id. 15 Id. at 69.

PAGE 125

125 mere two hundred inspectors in 2004 were charged with the responsibility of enforcing all of the occupational safety/health, minimum wage, and child labor laws. 16 The risk of occupational diseases and acciden ts in Latin America is further exacerbated by high levels of informal employment; 17 since 1982, the informal sector has accounted for 80% of job creation in Latin America 18 and, as of 2007, accounted for nearly 50% of overall employment 19 Informal employers are much less likely to be monitored by the government for occupational health hazards and thus have less given high turnover in the informal sector, these employers are also less prone to satisfactorily train workers in safety protocols or how to handle hazardous materials. 20 Moreover, they seldom offer health insurance, and the lack of organized unions in the informal sector results in the lack of an advocate on beha lf of workers for health related changes. 21 It is estimated 22 that occupational accidents and diseases in Latin America are the cause of only 3% of deaths annually, but given that most work related deaths are suffered by those of relatively young age, a more refined analysis of the burden of 16 Id. at 47. 17 G IUFFRIDA supra note 5 at 4 5. 18 James J. Biles, Informal Work in Latin America: Competing Perspectives and Recent Debates 3 G EO C OMP ASS 214, 215 n.1 (2009). 19 ILO 2007 L ABOUR O VERVIEW L ATIN A MERICA AND THE C ARIBBEAN 23, available at http://www.ilo.org/wcmsp5/groups/public/ --americas/ --ro lima/documents/publication/wcms_185221.pdf. 20 G IUFFRIDA supra note 5 at 4 5. 21 Id. 22 This hig h level of informal unemployment also contributes to the widely held belief of underreporting of occupational diseases and accidents across Latin America. G IUFFRIDA supra note 5 at 8.

PAGE 126

126 23 and China and costing Latin America nearly 10% of its GDP annually. 24 As a point of comparison, the burden of occupational accidents and disease in the EU is only 3% of GDP. 25 Like access to medicine, different FTAs promote occupational health in varying ways, and this Chapter evaluates t he substantive and procedural provisions of these FTAs according to the impact of these provisions on the capacity of a state to meet its responsibilities under the ICESCR to progressively realize this componen t of the right to health and on the capacity of individuals and groups to have practicable access to this area of the right to health in the manners described by ILO and WHO documents. Section 1 examines the substantive occupational health provisions in In ternational Labour Organization (ILO) and WHO conventions, and Sections 2 5 analyze the impact on occupational health of NAFTA, the Jordanian FTA, CAFTA (between the U.S. and Colombia, Panama, and Peru), res pectively. Based on the analyses of those FTAs, Section 6 provides a framework for ideal FTA provisions addressing occupational health. 23 YPLL measures premature mortality by calculating the numeric differ ence between a predetermined end point age (typically, seventy five years of age) and the age at death for a death that occurred prior to that end point age. Years of Potential Life Lost N ATIONAL A SSOCIATION FOR P UBLIC H EALTH S TATISTICS http://www.naphsi s.org/Documents/YPLL.pdf. 24 Id. at 15. 25 E UROPEAN A GENCY FOR S AFETY AND H EALTH AT W ORK N ATIONAL E CONOMICS AND O CCUPATIONAL S AFETY AND H EALTH 1 (2007), available at https://osha.europa.eu/en/publications/factsheets/76.

PAGE 127

127 Section 1: Occupational Health Standards under ILO and WHO Conventions Under the Universal Declaration of Human Rights (UDHR), which constitutes binding customary international law, 26 27 ht to work, protected in both the UDHR and the ICESCR 28 Due to this connection with the workplace, the steps to ditions of work with respect to 29 and while this provision has not been incorporated into the ILO core labor standards, 30 the ILO has adopted several conventions which address occu pational health, such as the Occupational Safety and Health Convention and the Occupational Health Services 26 Eleanor D. Kinney, The Internatio nal Human Right to Health: What Does This Mean for our Nation and World 34 I ND L. R EV 1457, 14 64 (2001). 27 The Universal Declaration of Human Rights art. 23( 1 ) G.A. Res. 217, U.N. GAOR, 3d Sess., U.N. Doc. A/810 (1948) [ hereinafter UDHR]. 28 ICESCR, sup ra note 2 at Art. 7(b); U.N. Econ. & Soc. Council, Comm. on Econ., Soc. and Cultural Rights, General Comment No. 18(12(c)): The Right to Work, U.N. Doc. E/C.12/GC/18 (Feb. 6, 2006) [ hereinafter ICESCR General Comment 18] 29 Charles B. Rangel, Moving Forwa rd: A New Bipartisan Trade Policy that Reflects American Values 45 H ARV J. ON L EGIS 377, 390 91 (2008); USTR to push for 12 years of Data Exclusivity for Biologics in TPPA I NSIDE U.S. T RADE (May 30, 2011), http://donttradeourlivesaway.wordpress.com/201 1/05/30/ustr to push for 12 years of data exclusivity for biologics in tppa/ ; Roman Grynberg & Veniana Qalo, Labour Standards in US and EU Preferential Trading Arrangements I NTERNATIONAL T RADE AND R EGIONAL C O OPERATION : E CONOMIC A FFAIRS D IVISION M ARLBORO UGH H OUSE P ALL M ALL L ONDON available at http://www.thecommonwealth.org/Shared_ASP_ Files/UploadedFiles/B9B769AA 9547 4CCE 8392 B2CC93E62A3D_Labour StandardsinUSandPreferentialTradeArrangements.pdf (last visited Dec. 8, 2012). 30 The ILO adopted the ILO Declaration on Fundamental Principles and Rights at Work which recognized (a) freedom of association and the effective recognition of the right to collective bargaining; (b) the elimination of all forms of forced or compulsory labour; (c) the effective abolition of child labour; and (d) the elimination of discrimination in respect of ILO Declaration on Fundamental Principles and Rights at Work art. 2 (1998), availabl e at http://www.ilo.org/declaration/thedeclaration/textdeclaration/lang -en/index.htm.

PAGE 128

128 Convention, conventions which address specific risks (such as hazardous chemicals) and codes of practice to provide templates for national laws rega rding safety and health in the workplace. Occupational Safety and Health Convention Turning first to the Occupational Safety and Health Convention, 31 this Convention provides that every worker, regardless of the economic sector, size of the company, or sort of assignment or occupation within which the worker is employed, has a right to occupational health and safety 32 Each state party to this convention is called to injur y to health arising out of, linked with or occurring in the course of work, by minimi[z]ing, so far as is reasonably practicable, the causes of hazards inherent in the 33 Furthermore, these policies should address the key elements of wo machinery and equipment, chemical, physical and biological substances and work equipm information, training, and certification regarding the proper installation, use, and hazards of machi nery, equipment, and biochemical agents; communication among all levels of 31 ILO, C155 Occupational Safety and Health Convention, 1981 (No. 155), 67th ILC sess. Geneva, (entered into force Aug. 11, 1983), available at http://www. ilo.org/dyn/ normlex/en/f?p=1000:12100:0::NO::P12100_INSTRUMENT_ID:312300. 32 Id. at art. 2. 33 Id. at art. 4(2).

PAGE 129

129 the workplace; and protection of workers who voice health and safety concerns. 34 State parties are called to establish laws and regulations to give effect to those national policies and to enforce them through inspections, monetary penalties, and the progressive realization of regulations regarding the determination of banned or limited work processes or substances in the workplace, establishment of mandatory trainings for the use of certain types of equipment, and notification, investigation, and publication of occupational accidents and disease incidents. 35 The Protocol of 2002 to the Occupational Safety and Health Convention 36 provides further standards for the reporting of occupatio nal accidents, occupational diseases (and suspicions of possible diseases), dangerous occurrences (events, defined under law or regulation, that may result in death or personal injury to an employee or member of the public), commuting accidents (between th e workplace and meal or receives remuneration) and suspected cases of occupational diseases and delineates the responsibilities of employers and state authorities. 37 Of par ticular note are the duties of employers to provide information to employees on how to report disciplinary measures against a worker for reporting an occupational accident, occupational disease, dangerous occurrence, commuting accident or suspected case of 34 Id. at art. 5. 35 Id. at arts. 5(c), 8, 9, 11. 36 Protocol of 2002, supra note 3 37 Id. at arts. 1 7.

PAGE 130

130 38 Regarding Latin America, Brazil, El Salvador, Mexico, and Uruguay have ratified the Occupational Safety and Health Convention, and only El Salvado r has ratified the Protocol of 2002. 39 Occupational Health Services Convention The Occupational Health Services Convention 40 ing and maintaining a safe and healthy working environment which will facilitate optimal physical and mental health in relation to work [and] the adaptation of work to the capabilities of workers in the light of their state of physical and mental 41 Analogous to the Occupational Heal th and Safety Convention, state parties to strengthen occupational health services for workers in every economic sector. 42 As occupational health services are progressively developed, they should include the following functions where appropriate: evaluation of health hazards in the work 38 Id. at art. 3(a)(ii, iv). 39 Ratifications of C155 Occupational Safety and Health Convention, 1981 (No. 155) ILO (2012), http://www.ilo.org/dyn/normlex/en/f?p=1000:11300:0::NO:11300:P11300 _INSTRUMENT_ID:312300; Ratifications of P155 Protocol of 2002 to the Occupational Safety and Health Convention, 1 981, ILO (2012), http://www.ilo.org /dyn/normlex/en/f?p= NORMLEXPUB:11300: 0::NO:11300:P11300_INSTRUMENT_ID:312338:NO. 40 ILO, C161 Occupational Health Services Convention, 1985 (No. 161), 71 st ILC Session Geneva, (entered into force Feb. 17, 1988), avai lable at http://www.ilo.org/dyn/normlex/en/f?p=NORMLEXPUB:12100:0::NO:12100:P12100_INSTRUMENT_ID:3 12306:NO. 41 Id. at art. 1(a). 42 Id. at arts. 2, 3(1).

PAGE 131

131 nce of the factors in the working environment and working practices which may affect workers' health, including sanitary installations, canteens related aspects of machi nery and equipment, vocational rehabilitation services, education regarding occupational hygiene, the installation of and training for protective equipment and security devices, and first aid/emergency treatment. 43 State parties are called to establish occ upational services through laws and regulations and collective agreements among employers and employees. 44 Regarding Latin America, Brazil, Chile, Colombia, Guatemala, Mexico, and Uruguay have ratified the Occupational Health Services Convention. 45 WHO Furth ermore, the World Health Organization (WHO) Constitution delineates that 46 In the 1994 Global Strategy on Occupational Health for health is broadly defined as encompassing access to primary healthcare for all workers, limiting or preventing access to hazardous agents, disease prevention, physical and 43 Id. at art. 5. 44 Id. at art. 6. 45 Ratifications of C161 Occupational Health Services Convention, 1985 (No. 161) ILO (2012), http://www.ilo.org/dyn/normlex/en/f?p=1000:11300:0::NO :11300:P11300_INSTRUMENT_ID:312306. 46 Global strategy on occupational health for all: The way to health at work WHO (2012), www.who.int/occupational_health/publications/gl obstrategy/en/index5.html.

PAGE 132

132 mental health promotio 47 occupational health and safety provide good opportunities for improving the health of workers and promot[ing 48 Given these documents which elucidate the steps that states ought to take to promote safe and healthy working conditions and thus progressively realize access to the right to health for their populations, the nex t question becomes how to best execute and enforce these steps. Of particular concern is enforcement since ILO conventions incorporate reporting requirements but lack enforcement mechanisms. As with access to essential medicines in Chapter I, FTAs offer an advantageous avenue for bolstering access to health in the workplace through the incorporation of provisions into FTAs which address the steps called for by the ILO and WHO regarding occupational health and, most importantly, provide methods for the execu tion and enforcement of these Moreover, enforcing substantively equivalent occupational health provisions among states in a FTA can lower costs), and FTAs even offer a framework for positive change through setting, sharing of the technical information on which standards are based and harmonization of disparate standards up to high levels 49 FTAs such as 47 Id. Occupational Health Stresa, Italy, (June 8 9, 2006), available at http://www.who.int/occupational_health/Declarwh.pdf. 48 Declaratio supra note 47 at 5. 49 Howard Frumkin, Free Trade Agreements: Chapter 20 Development, Trade, and Technology in ILO E NCYCLOPEDIA OF O CCUPATIONAL H EALTH AND S AFETY (4 th ed.) (ILO: 1998), available at http://ilocis.org/documents/chpt 20e.htm#JD_Figure20.1.

PAGE 133

133 NAFTA, the Jordanian FTA, CAFTA promote occupational health in varying ways, and the following sections evaluate their Section 2: NAFTA NAFTA was the first FTA to significantly incorporate labor provisions. 50 labor provisions are delineated in a side agreement which was the result of the 1992 U.S. presidential election of Bill Clinton. 51 President George H.W. Bush h ad already negotiated NAFTA during his term, but forecasts of substantial job losses stemming from the implementation of NAFTA became a significant campaign issue with Ross Mexico. 52 Clinton crafted a compromise position by negotiating a side agreement to NAFTA (after his election it would be too late to restart negotiations of the main agreement). 53 The resulting North American Agreement on Labor Cooperation (NAALC) went into effect with NAFTA on January 1, 1994. 54 50 M ARY J ANE B OLLE NAFTA L ABOR S IDE A GREEMENT : L ESSONS FOR THE W ORKER R IGHTS AND F AST T RACK D EBATE C.R.S. R EPORT 97 861 E at Summary (Oct. 9, 2001), available at http://fpc.state.gov/documents/organization/6211.pdf. 51 Marley S. Weis s, Two Steps Forward, One Step Back Or Vice Versa: Labor Rights Under Free Trade Agreements From NAFTA through Jordan, via Chile, to Latin America, and Beyond 37 U.S.F. L. R EV 689, 702 (2003). 52 Id. 53 Id. 54 B OLLE supra note 5 0 at 1.

PAGE 134

134 Provisions Annex 1 of NAALC delineates eleven guiding labor principles which the state domestic law, but do not establish common minimum standards for their domestic law. 55 The ninth principle is standards to minimize the causes of occupational injuries and 56 Article 2 further clarifies that NAALC contains no substantive standards for labor laws: to adopt or modify accordingly its labor laws and regulations, ea ch Party shall ensure that its labor laws and regulations provide for high labor standards, consistent with high quality and productivity workplaces, and shall continue to strive to improve those 57 While NAALC does nothing to advan ce the substantive provisions of the afore described ILO occupational health convent ions, it does call for state compliance with and effectively enforce its labor law through appropriate government ons. 58 establishment of a process for complaints to be brought regarding the failure of state parties to effectively enforce their laws relating to the eleven guiding labor principles; moreover, prevention of occupa tional illness and injuries, along with child labor 55 North America n Agreement on Labor Cooperation, Can. Mex. U.S., Annex 1, Sept. 14, 1993, 32 I.L.M. 1499, 1515 [ hereinafter NAALC]. 56 Id. at 1516, Annex 1(9). 57 Id. at 1503, art. 2. 58 Id. at 1503, art. 2.

PAGE 135

135 protections and minimum wage standards, are the three principles for which sanctions may be issued as a consequence for failure to enforce related laws. 59 su bmission National Administrative Office (NAO) of another state party. 60 Each state party has a NAO within its labor department to receive submission s, ascertain their validity, and determine if and what steps are to be taken in response. 61 If the NAO to which the submission is brought chooses to pursue it, the first step is collaborative consultations between that NAO and the NAO of the state in which the issue raised in the submission occurred; if the issue is not resolved during those consultations, 62 then the NAO may refer it to the Ministerial Council (MC) (composed of t he labor ministers of the state parties) 63 If the MC also fails to resolve the is patterns of in enforcing standards regarding the prevention of occupational illnesses and injuries, is trade related, and is covered by mutually recognized labor laws then either the MC or a state party may refer t he submission to a three member Evaluation Committee of Experts (ECE). 64 An ECE is created from a standing list of experts and has the power to investigate the issue and make recommend ations to the MC to which 59 M ARY J ANE B OLLE J ORDAN U.S. F REE T RADE A GREEMENT : L ABOR I SSUES C.R.S. R EPORT 97 RS20968 at 6 (May 27, 2003), available at http://assets.opencrs.com/rpts/RS20968_20030527.pdf. 60 NAALC, supra note 55, at 1507, art. 16(c). 61 B OLLE supra note 5 9 at 7. 62 Id. at 1507, art. 21. 63 Id. at 1508, art. 22. 64 Id. at 1508, art 23.

PAGE 136

136 state parties may respond. 65 If resolution is st be referred to a five member Arbitral Panel (AP). 66 The AP will then ascertain whether persistent patte rn of failure [of a state party] to effectively enforce plan. 67 If these recommendations/actions plan are not executed, then the AP may issue a monetary enforcement asses sment to be used by the violating state party to bolster enforcement of the neglected laws. 68 However, if the assessment is not paid, sanctions may be imposed with maximum penalties being suspension of NAFTA benefits to the amount of the monetary assessment (which may be no greater than NAFTA benefits from tariff reductions) for one year. 69 Complaints brought under the Provisions of NAALC Since 1994, eight submissions have been brought before the U.S. NAO for failure of Mexico to effectively enforce its occu pational health and safety laws. 70 Five were referred to the MC, one was resolved at the NAO level, one was withdrawn, and one was denied review by the U.S. NAO. 71 Issues raised in the submissions included high levels of asbestos, lack of protective equipmen t, insufficient training in the handling 65 Id. at 1508, art. 24. 66 Id. at 1509, art. 29. 67 Id. at 1509, art. 29. 68 Id. at 1512, art. 41. 69 Id. 70 Status of Submissions under the NAALC U.S. D EPARTMENT OF L ABOR http://www.dol.gov/ilab/programs/nao/status.htm#.UMzkV3ewWSo (last viewed Dec. 15, 2012). 71 Id.

PAGE 137

137 of chemical substances, toxic warnings not written in Spanish, hearing loss, respiratory disease, inoperative safety equipment, and lack of training in the usage of safety equipment. 72 Results from these submissions ranged from the establishment of working groups of occupational health experts to determine solutions, a Mexican public awareness campaign regarding governmental legal assistance available to workers in cases related to the protection from and compensation for occupational injuries and diseases, the ceasing of compulsory pregnancy testing of female public employees and dismissal if pregnant (though this practice persists in the private sector), 73 and, in one instance, the transfer of workers to a safer facil ity 74 Other general positive effects of NAALC include increased cross border NGO cooperation, slightly increased transparency (NAOs are to provide each other with any relevant publicly available information when discussing a submission), and heightened att ention by the press to issues raised in NAALC submissions. 75 However, it has been argued that the positive power of the NAALC dispute resolution process has been curtailed by how individuals and groups are free to make submissions to national NAOs, but then it is entirely the prerogative of NAOs and then national Labor Ministers to take the next necessary steps for investigating alleged lack of effective enforcement of labor laws. Furthermore, regarding occupational health, no submissions have reached the E CE or AP stages. 72 L INDA D ELP M ARISOL A RRIAGA G UADALUPE P ALMA H AYDEE U RITA & A BEL V ALENZUELA S L ABOR S IDE A GREEMENT : F ADING INTO O BLIVION ? A N A SSESSMENT OF W ORKPLACE H EALTH & S AFETY C ASES 49, 51 (UCLA C ENTER FOR L ABOR R ESEARCH AND E DUCATION 200 4), available at http://www.labor.ucla.edu/publications/pdf/nafta.pdf. 73 Sandra Polaski Protecting Labor Rights through Trade Agreements: An Analytical Guide 10 U.C D AVIS J. I NT L L. & P OL Y 13 24 (2003). 74 Id. 75 D ELP supra note 72 at 22 24.

PAGE 138

138 Effects states to meet their responsibilities under the right to health relating to safe and healthy working conditions has been largely li l for state parties to cooperate regarding the promotion of the eleven labor principles 76 which has spawned d] have encouraged development of a tri 77 among labor unions, NGOs, governments, and employers. However, NAALC did not create any specific mechanisms for that burgeoning knowledge to be channeled into effecting measurable positive changes have been largely constrained to the ability to make submissions to national NAOs. Additionally, NAALC largely fails as a tool for promoting the establishment of the substant ive provisions of the ILO occupational health conventions as law and enforcing delineate substantive requirements for progressive changes in occupational health laws an d regulations. Enforcement is also constrained by the NAO submission process, and this is further restricted by how A rticle 43 of NAALC bars a state party from providing for a right of action under its domestic law against another state party on the ground s that it 76 NAA LC, supra note 5 5 at 1505, art. 11. 77 B ENJAMIN H OLT & M ICHAEL W ALLER I NTERNATIONAL T RADE AND W ORKERS R IGHTS : P RACTICAL T OOLS FOR R EADING L ABOR R IGHTS P ROVISIONS OF F REE T RADE A GREEMENTS 44 (2011), available at http://www.wcl.american.edu/hrbrief/11/3hol t.pdf.

PAGE 139

139 had failed to effectively enforce its laws relating to occupational health and safety. 78 One proposed amendment to NAFTA (though extremely unlikely) and also a proposed provision for future FTAs is the incorporation of an express private right of action for workers, unions, and other groups to bring legal actions against corporations whi ch operate in two or more state parties in the domestic courts of one of those states for FTA violations 79 In addition, parent corporations could be made fully lia ble for FTA violations of their subsidiaries and, if liable, incur loss of trade benefits under the FTA. 80 Section 3 : U.S. Jordan FTA Provisions Akin to its provisions regarding access to medicine, the U.S. Jordan FTA (Jordanian FTA) contains occupational health provisions that mark a departure from right of each Party to establish its own domestic labor standards each Party shall strive to ensure that its laws pro vide for labor standards consistent with the internationally recognized labor rights set forth in paragraph 6 and shall strive to improve those standards in that light conditions of work with respect to occ 81 The key distinctions from NAFTA are that these provisions appear in the body of the text, not in a side agreement, and state parties are bound to go beyond the effective execution of 78 NAALC, supra note 5 5 at 1513, art. 43. 79 North American Free Trade Agreement and Labor Rights, I NTERNATIONAL L ABOR R IGHTS F UND (1995), http://www.iatp.org/files/North_American_Free_Trade_Agreement_and_Labor_.htm. 80 Id. 81 Agreement Between the U nited States of America and the Hashemite K ingdom Of Jordan on the Establishment of a Free Trade Area art. 6(3, 6(e)), 41 I.L.M. 63 (2002) [ hereinafter Jordanian FTA].

PAGE 140

140 national labor laws (compulsory under both NAFTA and the Jordanian FTA 82 ) to make good faith efforts to ensure that domestic laws establish standards for occupational health and safety which are consistent with international standards. However, this provision is markedly softened by use of the ter 83 Nevertheless, a related to occupational safety and health could be framed in the same manner as the state has failed to use its best efforts and take continual steps to progressively realize safe and healthy working co nditions. 84 Under the dispute resolution mechanisms of the Jordanian FTA, one of the state usly strengthen those laws. 85 (Like NAFTA, there is no mechanism for individuals or groups to initiate a complaint; they can only make submissions to the state parties.) 86 If consultations between the state parties are fruitless, then the iss ue could be refe rred by a state party to a special session of the Joint Committee (composed of repres entatives of the two state parties and chaired by the U.S. Trade Representative and his Jordanian 82 Id. at art. 6(4). 83 Id. at art. 6(3 4). 84 See Jeremy Sarkin & Mark Koenig, Developi ng the Right to Work: Intersecting and Dialoguing Human Rights and Economic Policy 33 H UM R TS Q. 1, 3 (2011). 85 Jordanian FTA, supra note 81, at art. 17(1)(b). 86 H OLT supra note 77 at 43.

PAGE 141

141 counterpart). 87 If the Joint Committee is unable to resolve the dispute, t hen a dispute settlement p anel will be formed (each state party will choose a representative and those two representatives will choose a third). 88 The panel will investigate and provide a non binding report to the Joint Committee. 89 If, after analyzing the r eport, the Joint Committee is still unable to reso lve the dispute, then the state party which brought the 90 which is presumed to encompass sanctions or loss of benefits under the Jordanian FTA 91 Unlike NAFTA, there is no provision in this FTA calling for cooperation in promoting occupational safety and health, 92 but cooperation between the U.S. and Jordan has nonetheless blossomed. One example is ILO: Better Work Jordan (BWJ). Funded [annually] by Jordan (US$1.05 million), USAID (US$2.7 million) and factory participation fees (US$0.58 million) factory assessments undertaken by BWJ include child labour, forced labour, trafficking, wages, working hours, occupational safety and health, a nd dormitory conditions. Though initially a voluntary program 93 The ILO also 94 87 Jordanian FTA, supra note 81 at art. 17(1)(b). 88 Id. at ar t. 17(1)(c). 89 Id. at art. 17(1)(d). 90 Id. at art. 17(1)(c). 91 B OLLE supra note 5 9 at 2; H OLT supra note 77, at 43. 92 H OLT supra note 77 at 44. 93 L EJO S IBBEL T HE L ABOUR P ROVISIONS IN THE U.S. J ORDAN F REE T RADE A GREEMENT : I MPACT AND L ESSONS L EARNT 7 (April 26, 2010), available at

PAGE 142

142 Effects In terms of a human rights impact assessment, cooperative activities like BWJ conditions. Regarding the capacity of individuals and groups to have practicable access to this area of the right to health in t he manners described by ILO and WHO documents, the provision in Article 6(3) delinea ting that state ccess if such laws are enacted and continuously improved. No evidence was found of a violation being brought before the Joint Committee regarding this article, so its practical efficacy for Jordanians is not clear. However, it provides a strong model for f uture FTAs, a model which could be further bolstered through specifically delineating that the labor standards consistent with occupational health and safety are those delineated in the ILO Occupational Safety and Health Convention, ILO Occupational Health Services Convention, and WHO Declaration on te complaints regarding a state to those standards. Section 4: CAFTA DR Provisions CAFTA DR Article 16.1.2 encompasses the same language as the Jordanian http://www.americanbar.org/content/dam/aba/administrative/labor_law/meetings/2010/2010_intl_sibbel.au thcheckdam.pdf. 94 Id. at 9 10.

PAGE 143

143 each Party shall strive to ensure that its laws provide for labor standards c onsistent with the internationally recognized labor rights set forth in Article 16.8 and shall strive to d in Article 16.8(e). 95 Again using enforce its labor laws, through a sustained or recurring course of action or inaction, in a 96 The weighty difference between these two FTAs lies in dispute resolution: only the persistent failure of a state party to enforce its own labor laws is subject to binding dispute settlement and sanctions under Article 20; alternatively, obligations under Article 16.1.1 2 to strive to ensure that acceptable conditions of occupational health and safety are recognized and protected by law, that these laws are consistent with international standards, and to improve these laws are not subject to binding dispute resolution and sanctions. 97 During CAFTA DR discussions in the U.S. House of Representatives Ways and Means Committee, several Representatives argued that since Central American states needed assistance in both strengthening and enforcing labor laws, merel y compelling enforcement was inappropriate. 98 acceptable results. Indeed, Congress would never approve an agreement that requires 95 Dominican Republic Central America U.S. Free Trade Agreement, arts. 16.1.2, 16.8(e) ., Ma y 28, 2004, available at www.ustr.gov/assets/Trade_ Agreements/Regional/ CAFTA/ CAFTA DR_Final_Texts/asset_upload_file934_3935.pdf [ hereinafter CAFTA DR]. 96 Id. at art. 16.2.1(a). 97 B OLLE supra note 5 9 at 2; see CAFTA DR, supra note 95 at arts. 16.6.6 16.7.3, 20.17.1. 98 Dominican Republic Central America United States Free Trade Agreement Implementation Act, H.R. Rep. No. 109 182, at 50 (2005), as reprinted in 2005 U.S.C.C.A.N. 337, 344 [ hereinafter Ways and Means Report].

PAGE 144

144 merely that our trading partners enforce their existing laws in o ther areas, such as 99 Instances of these inadequate laws are found in Honduras and the DR where workers have neither the legal right to remove themselves from unsafe working conditions nor legal protection from their employers if they choose to leave regardless. 100 Concerning dispute resolution for failure to effectively enforce current labor laws, under Article 16.6.1, one state party may request government to government c onsultations with another state party regarding the alleg ed lack of effective enforcement of a labor law in the territory of that state. 101 S tate parties must cooperate to attempt to form a solution and in doing so may obtain technical assistance or establish expert working groups; 102 if a solution is not reached af ter sixty days, then a state party may call for a meeting of the Free Trade Commission (composed of cabinet lev el representatives of the state parties, as delineated in Annex 19.1, or their designees) 103 If a solution is not reached within thirty days of th e Free Trade Com mission meeting, then the state party which requested that meeting may request that an arbitral panel of three individuals be assembled. 104 CAFTA DR calls for the institution of a roster of individuals to serve as panelists in matters of labo r dispute. 105 99 Id. 100 CAFTA L ABOR R IGHTS R EPORT supra note 11 at 47, 117. 101 CAFTA DR, supra note 95 at art. 16.6.1. 102 Id. at arts. 16.6.5, 20.5.4(a). 103 Id. at art. 20.5.1(a). 104 Id. at art. 20.6.1(a). 105 Id. at art. 16.7.1.

PAGE 145

145 expertise or experience in labor law or its enforcement, internat ional trade, or the 106 The panel then conducts a review of the alleged lack of effective enforcement; 107 if the panel finds that a state party is not effectively enfor cing its law(s), then the s tate parties themselves have an opportunity to resolve the dispute through a mutually satisfactory action plan 108 If the dispute cannot be cooperatively resolved, then an annual monetary penalty of a maximum of $15 million (USD) may be im posed until the vio lating state party comes into compliance. 109 The penalty payments are deposited in a fund to be used for labor initiatives such as enforcement of the unenforced la w in the territory of the state party in violation. 110 If that state party fails to p ay the penal ty, the other state party may take steps to collect, such as the temporary suspension of tariff benefits equivalent to the value of the penalty; however, the decision to suspend trade benefits must be balanced trade and while seeking to avoid unduly 111 A third obligation under CAFTA DR Article 16 (though again not subject to dispute resolution and sanctions unde r Article 20) is that the state parties will establish a 106 Id. at art. 16.7.2(a c). 107 Id. at art. 20.13.3(a c). 108 Id. at art. 20. 15.3. 109 Id. at art. 20.17.2. 110 Id. at art. 20.17.4. 111 Id. at art. 20.17.5.

PAGE 146

146 Labor Cooperation and Capacity Building Mechanism (CBM) in order to foster commitments regarding labor matters 112 region 113 The U.S. government provided over $1 42 million (USD) to th e CBM between 2005 and 2010, and priorities for expenditures stemmed Responsible for Trade and Labor in the Countries of Central America and the Dominican Republic. 114 One $3 million project implemented by Social Accountability International (SAI) focused on particular agricultural communities in Honduras, Nicaragua, and the DR to develop and execute action plans to advance compliance with occupational safety and health reg ulations and bolster mechanisms for workers to exercise their rights. 115 An additional $2 million was directed to Continuous management on how to exercise rights and responsibil ities under ILO conventions, 112 CAFTA DR, supra note 95 at art. 16.5.1. 113 Id. at Annex 16.5.3(g). 114 CAFTA DR Labor Capacity Building O FFICE OF THE U NITED S TATES T RADE R EPRESENTATIVE (May 2011), http://www.us tr.gov/about us/press office/fact sheets/2011/may/cafta dr labor capacity building. 115 Id. ; DR CAFTA AND W ORKER S R IGHTS : M OVING FROM P APER TO P RACTICE 7 (Washington Office on Latin America May 18, 2009), available at http://www.strtrade.com/media/publicati on/911_2009 May 18 wola_dr_cafta_rpt_final.pdf.

PAGE 147

147 safety. 116 CIMCAW has provided information on labor rights to 40,000 people, trained over 400 workers in the DR, Guatemala, and Honduras, train ed over 300 inspectors in national Ministries of Labor, and written training manuals. 117 Complaints brought under the Provisions of CAFTA DR While several claims have been submitted to arbitration under the provisions delineated in CAFTA DR Article 10 Secti on B: Investor State Dispute Settlement, 118 the first 119 request for the establishment of an arbitral panel to investigate the alleged failure of a state party to effectively enforce its labor laws was by the U.S. on August 9, 2011, regarding Guatemala. 120 On Ju ly 30, 2010, the U.S. had, pursuant to CAFTA DR Article results of an eleven month long investigation. 121 The collection and analysis of factual and legal evidence had identified specific instances, regarding the laws protecting the Guatemalan state actors to investigate alleged violations, take legal 116 DR CAFTA AND W ORKER S R IGHTS : M OVING FROM P APER TO P RACTICE supra note 115 at 6. 117 Id. 118 Luke Eric Peterson, CAFTA Labour Arbitration Should Play Out on Fast Track K LUWER A RBITRATION B LOG (August 15, 2 011), http://kluwerarbitrationblog.com/ blog/2011/08/15/cafta labour arbitration should play out on fast track/. 119 No other requests for arbitral panels under Article 20 were found during the research process, as of December 18, 2012. 120 U.S. Trade Represe ntative Ron Kirk Announces Next Step in Labor Rights Enforcement Case against Guatemala O FFICE OF THE U NITED S TATES T RADE R EPRESENTATIVE (August 9, 2011), http://www.ustr.gov/about us/press office/press releases/2011/august/us trade representative ron kir k announces next ste. 121 K IRK S OLIS L ETTER TO G UATEMALA ABOUT L ABOR R IGHTS V IOLATIONS 1 (July 30, 2010), available at http://www.ustr.gov/webfm_send/2114.

PAGE 148

148 action once a violation had been confirmed, and enforce orders granted by the Labor Court. 122 The U.S. and Guatemalan governments then held two rounds of consultations, and in May 2011, th e U.S. Trade Representative (USTR) requested a meeting of the Free Trade Commission to review the allegations. 123 After a meeting of the Free Trade Commission on June 7, 2011, significant efforts were made to agree upon a satisfactory enforcement plan, but t hose efforts were ultimately fruitless. 124 According to USTR Ron proposals to date have been insufficient to address the apparent systemic failures. We need to see concrete acti ons to protect the rights of workers as agreed under our trade agreement, and we are prepared to act to obtain enforcement of those rights when and 125 Guatemalan Economy Minister Luis Velasquez responded to the arbitral panel request by ar guing that there was no basis for the allegations of lack of enforcement. 126 No evidence was found regarding whether an arbitral panel was established and, if so, the results of its review. Effects In terms of a human rights impact assessment, the CBM has p rovided opportunities a nd funding for bolstering state 122 Id. at 1 2. 123 U.S. Trade Representative Ron Kirk Announces Next Step in Labor Rights Enforcement Case against Guatemala supra note 120. 124 Id. 125 Id. 126 Dustin Ensinger, Guatemala Says it Will Win Trade Case Against U.S. E CONOMY IN C RISIS (Sep. 10, 2011), http://economyincrisis.org/content/guatemala says it will win trade case against us.

PAGE 149

149 effect positive change is constrained to enforcing provisions already enacte d as domestic law since CAFTA DR fails to delineate substantive requirements for occupational health laws and regulations or promote the establishment of the substantive provisions of the ILO occupational health conventions as law. Instead of building upon DR was a step backwards. Among the CAFTA DR states, only El Salvador has ratified the Occupational Health and Safety Convention and Guatemala the Occupational Health Services Convention; ther efore, there is ample room for improvement by calling upon the othe r state laws. And while laws on the books are not helping anyone if not enforced, given CAFTA chanism, there is an increased probability that such laws would be more strongly enforced due to increased public and international awareness and the threat of sanctions. Regarding access of individuals and groups to they can attem pt to draw attention to a state force its labor laws, but state parties have complete discretionary power regarding what investigatory steps to take after an alleged instance of lack of enforcement in another state party is brought to their attention. Provisions As previously noted, many U.S. Congressmen were concerned about the dearth re cognized 127 As a result, they fought to ensure that a true 127 Rangel, supra note 29 at 390.

PAGE 150

150 formed the basis of access to medicine, environmental, and labor provisions in the U.S. FTAs with Colombia, Panama, and Peru. 128 Under these FTAs, Each Party shall adopt and maintain in its statutes and regulations, and practices there under, the following rights, as stated in the ILO Declaration on Fundamental Principles and Rights at W ork and its Follow up (1998) (ILO Declaration): (a) freedom of association; (b) the effective recognition of the right to collective bargaining; (c) the elimination of all forms of compulsory or forced labor; (d) the effective abolition of child labor and, for purposes of this Agreement, a prohibition on the worst forms of child labor; and (e) the elimination of discrimination in respect of employment and occupation. 129 These are the first FTAs in which the failure to respect, protect, and fulfill ILO ob ligations will result in identical consequences as violations of any other FTA provision. 130 This provision is significantly stronger than its counterparts in CAFTA DR an d the Jordanian FTA since state 131 ) and this provision is subject to the same dispute resolution 128 Id. 129 United States Colombia Trade Promotion Agreement, U.S. Colom., art. 17.2.1, Nov. 22, 2006 (entered into force May 15, 2012), available at http://www.ustr.gov/trade agreements/free trade agreements/colombia fta/final text [ he reinafter U.S. Colombia FTA]; United States Panama Trade Promotion Agreement, U.S. Panama, art. 16.2.1, June 28, 2007, (entered into force Oct. 31, 2012), available at http://www.ustr.gov/trade agreements/free trade agreements/panama tpa/final text [ herein after U.S. Panama FTA]; United States Peru Trade Promotion Agreement, U.S. Peru, art. 17.2.1, Apr. 12, 2006 (entered into force Feb. 1, 2009), available at http://www.ustr.gov/trade agreements/free trade agreements/peru tpa/final text [ hereinafter U.S. Per u FTA]. 130 Rangel, supra note 29 at 390. 131 CAFTA DR, supra note 95 at art. 16.1.2.

PAGE 151

151 mechanisms as all other provisions 132 Like the other FTAs, each state fail to effectively enforce its labor laws through a sustained or recurring course of ac 133 However, u nlike previous FTAs, each state the right to exercise discretion with respect to investigatory, prosecutorial, regulatory, 134 regarding these laws Additionally, CAFTA DR state p arties 135 But under [a] decision a Party makes on the distribution of enforcement resources shall not be a reason for not complying with the provisions of this Chapter. Each Party retains the right to the reasonable exercise of discretion and to bona fide decisions with regard to the allocation of resources between labor enf orcement activities among the fundamental labor rights. 136 Of great relevance to this paper, however, state parties are only obliged to establish and execute laws related to the ILO core labor standards, which, unlike the do not encompass the potential for significantly more positive human rights impacts on other labor rights than previous FTAs, the same is not 132 Rangel, supra note 29, at 391. 133 U.S. Colombia FTA, supra note 129 at art. 17.3.1(a); U.S. Panama FTA, supra note 129 at art. 16.3.1(a); U.S. Peru FTA, supra note 1 29 at art. 17.3.1(a). 134 CAFTA DR, supra note 95 at art. 16.2.1(b). 135 Id. 136 U.S. Colombia FTA, supra note 129 at art. 17.3.1(b); U.S. Panama FTA, supra note 129 at art. 16.3.1(b); U.S. Peru FTA, supra note 129 at art. 17.3.1(b).

PAGE 152

152 State parties are merely bound to enforce labor laws which include those addressing occupational health and safety. 137 of CAFTA DR regarding cooperative labor consultations, 138 a meeting with the Free Trade Commission (cabinet level representatives of state p arties), 139 and the creation of an arbitral panel from an established roster 140 However, if the parties are unable to agr ort, then the complaining state party may suspend benefits under the FTA. 141 In determining k to suspend benefits in the same sector or sectors as that affected by the measure or other matter that the panel has found to be inconsistent with the obligations of this 142 If the violating state tly 143 Additionally, the violating party may pre empt the imposition of sanctions by paying a monetary 137 U.S. Colombia FTA, supra note 129 at art. 17.3.1(a), 17.8(f); U.S. Panama FTA, supra note 129 at art. 16.3.1(b), 16.9(f); U.S. Peru FTA, supra note 129 at art. 17.3.1(a), 17.8(f). 138 U.S. Colombia FTA, supra note 129 at art. 17.7.1; U.S. Panama FTA, supra note 129 at art 16.7.1; U.S. Peru FTA, supra note 129 at art. 17.7.1. 139 U.S. Colombia FTA, supra note 129 at art. 17.7.6; U.S. Panama FTA, supra note 129 at art. 16.7.6; U.S. Peru FTA, supra note 129 at art. 17.7.6. 140 U.S. Colombia FTA, supra note 129 at art. 21.6. 6 7. U.S. Panama FTA, supra note 129 at art. 20.6.6 7; U.S. Peru FTA, supra note 129 at art. 21.6.6 7. 141 U.S. Colombia FTA, supra note 129 at art. 21.16.2; U.S. Panama FTA, supra note 129 at art. 20.15.2; U.S. Peru FTA, supra note 129 at art. 21.16.2. 142 U.S. Colombia FTA, supra note 129 at art. 21.16.5(a); U.S. Panama FTA, supra note 129 at art. 20.15.5(a); U.S. Peru FTA, supra note 129 at art. 21.16.5(a). 143 U.S. Colombia FTA, supra note 129 at art. 21.16.3(a); U.S. Panama FTA, supra note 129 at art. 20.15.3(a); U.S. Peru FTA, supra note 129 at art. 21.16.3(a).

PAGE 153

153 determine d to be of equivalent effect or, if the panel has not determined the level, 50 144 The monetary assessment is paid to the complaining party unless the Free Trade Commission conclu des that circumstances warrant that the assessment goes into a facilitate trade between the disputing Parties including by further reducing unreasonable trade barriers FTA. 145 Notably, as opposed to CAFTA DR, monetary assessments are not limited to $15 million (USD); 146 this possible imposition of larger penalties could encourage states which are fo und to have not effectively enforced their labor laws to reach a cooperative solution with the complaining party or eliminate their non conformities with the terms of the FTA. If a state party does the latter and the arbitra l panel confirms that the state party is now in compliance, then the complaining state must reinstate trade benefits or the violating state may stop expending monetary assessments. Effects Labor Cooperation and Capacity Building Mechanisms 147 (identical to that called for in CAFTA DR) have been 144 U.S. Colombia FTA, supra note 129 at art. 21.16.6; U.S. Panama FTA, supra note 129 at art. 20.15.6; U.S. Peru FTA, supra note 129 at art. 21.16.6. 145 U.S. Colombia FTA, supra note 129 at art. 21.16.7; U.S. Panama FTA, supra note 129 at art. 20.15.7; U.S. Peru FTA, supra note 129 at art. 21.16.7. 146 CAFTA DR, supra note 95 at art. 20.17.2. 147 U.S. Colombia FTA, supra note 129 at art. 17.6; U.S. Panama FTA, supra note 129 at art. 16. 6; U.S. Peru FTA, supra note 129 at art. 17.6.

PAGE 154

154 eir more recent implementation: Peru in 2009 and Panama and Colombia in 2012). However, like CAFTA DR, they have the potential to bolster state ss to their human rights. State parties are bound to establish and enforce laws related to the ILO core labor rights, and they prosecutorial, regulatory, and compliance matters [regarding these laws] and to make decisions regarding the allocation of resources to enforcement with respect to other labor matters determined to of monetary assessments are not limited. However, like the previous agreements, ned by the re striction on state parties from creating a private right of action under their domest ic laws against the other state party on the grounds that the latter had failed to conform to its FTA o bligations. Additionally, state parties (not individuals or groups) must initiate cooperative labor consultations and the subsequent steps in the dispute resolution process. Section 6: Future FTAs Proposed Substantive Provisions From analyzing the impacts of these FTAs, it is clear that over time their potentials for posi tive impacts on human rights have expanded, but nevertheless, none

PAGE 155

155 Nonetheless, they do provide ideas for what one would look like. Building upon the FTAs, a model provision could delineate that: Each Party shall adopt and maintain in its statutes and regulations, and practices there under, the following rights, as stated in the ILO Declaration on Fundamental Principles and Rights at Work and its Follo w up (1998) (ILO Declaration), [in addition to] the Freedom of Association and Protection of the Right to Organise Convention 1948 (No. 87), the Right to Organise and Collective Bargaining Convention 1949 (No. 98), Forced Labour Convention 1930 (No. 29) the Abolition of Forced Labour Convention 1957 (No. 105), the Minimum Age Convention 1973 (No. 138), Worst Forms of Child Labour Convention 1999 (No. 182), the Equal Remuneration Convention 1951 (No. 100), the Discrimination (Employment and Occupatio n) Co nvention, 1958 (No. 111), 148 the Occupational Safety and Convention, 1981 (No. 155), and the Occupational Health Services Convention, 1985 (No. 161). This provision would require the adoption of laws regarding occupational health and by including ILO c onventions beyond the ILO Declaration states would be provided with a much more detailed framework for what their laws must address. This will streamline right to health will be significantly bolstered as states would know what steps they must take and for which steps they will require financial or techni cal assistance from other state parties, NGOs, or international organizat ions in executing. As all state parties in a conventions, this would greatly encourage cooperation among states and improve measuring and comparing progress among state be inserted to shield state parties from submissions of alleged violations of an 148

PAGE 156

156 as long as that state party was making good faith efforts to progressively realize that provision. Additionally, b enchmarks could be set by state parties and other organizations for compliance depending on the factual contexts of various situations. party will 149 regarding these l decision a [state p]arty makes on the distribution of enforcement resources shall not be a re 150 151 as delineated in CAFTA Proposed Dispute Reso lution Mechanisms Regarding enforcement, NAALC, CAFTA have very similar dispute resolution mechanisms (particularly the latter two). The differences lie in the amounts of monetary penalties. I believe that a mix of NAALC and if the recommendations/action plans of the arbitral panel (AP) are not executed, then the AP may issue a monetary enforcement assessment to be used by the violating s tate party to bolster enforcement of the neglected laws. 152 However, if the assessment is not paid, sanctions may be imposed with maximum penalties being the suspension of 149 CAFTA DR, supra note 95 at art. 16.2.1(b). 150 U.S. Colombia FTA, supra note 129 at art. 17.3.1 (b); U.S. Panama FTA, supra note 129 at art. 16.3.1(b); U.S. Peru FTA, supra note 129 at art. 17.3.1(b). 151 CAFTA DR, supra note 95, at art. 16.2.1(a). 152 Id. at 1512, art. 41.

PAGE 157

157 NAFTA benefits to the amount of the monetary assessment (which may be no greater than NAFTA benefits from tariff reductions) for one year. 153 the complaining state party receives the assessment unless the Free Trade Commission conclud es that circumstances warrant that the assessment goes into a facilitate trade between the disputing Parties including by further reducing unreasonable trade barriers o FTA. 154 progressively realize the right to health, I believe that, barring unusual circumstances, it is best for the monetary assessment to always be channeled back into the violating state (as under NAALC) but should be executed at the direction of the FTA Commission d to assist the vi olating state party in executing its obligations under the FTA. The Com mission and state parties could also cooperate with an organization like the Labor Cooperation and Capacity Building Mechanism (CBM) created under CAFTA DR and As to determine how to best expend the funds. Rewarding Positive Steps Coupled with using sanctions as a tool for effecting positive change instead of punishment (and possibly causing job losses or decreases in living standards of individuals in the viola ting state), future FTA negotiators should consider incorporating 153 Id. 154 U.S. Colombia FTA, supra note 129 at art. 21.16.7; U.S. Panama FTA, s upra note 129 at art. 20.15.7; U.S. Peru FTA, supra note 129 at art. 21.16.7.

PAGE 158

158 provisions like those in the U.S. Cambodia Bilateral Textile Agreement. Under that agreement, U.S. quotas of Cambodian textile imports increase as Cambodia meets improve enforcement of its own labor laws and to protect 155 Under this agreement, there have been quantifiable positive changes regarding respect and protection of Cambodian worke 156 Reasons for this success include that the possible quota increase is determined on annual basis, so there is a close temporal association between the behavior of the firms and government and the fruits of that good behavior. 157 Additionally, sin ce individual firms will benefit from the quota increase, it is in their best interest to comply voluntarily. 158 Also, since the quota increase hinges upon industry wide behavior, there is peer pressure from other firms for all to comply. 159 Fourthly, the ILO monitors the behavior of firms and the government and reports its results publicly. 160 Such an approach could be used in future FTAs to encourage states to take particular steps to progressively realize the right to health by easing trade restrictions that w ere not otherwise lifted under the terms of the FTA. 161 155 Polaski, supra note 73 at 13, 21. 156 Id. 157 Id. at 22. 158 Id. 159 Id. 160 Id. 161 Referencing back to restrictions on access to medicine in Chapters 2 3, lifting restrictions on ac cess regarding the progressive realization of the occupational health component of the right to health!

PAGE 159

159 Additional Steps to Boost Access to Healthy Working Conditions Lastly, given the provisions of enacted FTAs, it is critical, going forward, to bolster mechanisms for individuals and groups to make the ir voices heard. One possibility would be a transparent mechanism for review of complaints brought by individuals and group s for violations by other state parties of FTA provisions. 162 There could be a set protocol for reviewing the substantive and legal all egations of these complaints, consolidating complaints of similar allegations, and making the results and reasoning of the review publicly available in order to foster accountability and provide other groups and organizations with information for future co mplaints, advocacy efforts, further investigation regarding the allegations of denied complaints, and then possibly lobbying for the allegations of those complaints to be reviewed again. Another possibility (though unlikely) is removing the provision in f uture FTAs of barring state ts law against any other [state p]arty on t he ground that the other [state p ]arty has failed to conform with its [FTA] 163 More likely would be the incorporation in future FTAs of an express private right of action for workers, unions, and other groups to bring legal actions against corporations whi ch operate in two or more state parties in the domestic courts of 162 MERCOSUR provides a strong model in this regard; i n 2002, rules were enacted through CMC Decision 18/02, to provide greater transparency in the acceptance of complaints and uniformity in procedures for the review of those complaints. C ELINA P ENA & R ICARDO R OZEMBERG M ERCOSUR : A D IFFERENT A PPROACH TO I NSTI TUTIONAL D EVELOPMENT : F OCAL P OLICY P APER 9 (March 2005), http://www.focal.ca/pdf/mercosur _Pena Rozemberg_different%20approach %20institutional%20development_March%202005_FPP 05 06_e.pdf. 163 U.S. Colombia FTA, supra note 129 at art. 21.20; U.S. Panama FTA, supra note 129 at art. 20.19; U.S. Peru FTA, supra note 129 at art. 21.20.

PAGE 160

160 those state isions and holding parent corporations liable for the acts of their subsidiaries. 164 Conclusion By analyzing the human rights impacts of previously enacted FTAs, this Chapter has served to develop a framework for provisions of future FTAs to better foster c Pacific Partnership (TPP) to which the U.S., Chile, Mexico, and Peru 165 are parties to the ongoing negotiations of (the access to medicine provisions of the TPP were addressed in Chapter I) 166 While no drafts of the TPP labor chapter have been leaked, 167 Yet no mention wa s made of incorporating occupational health into the list of rights which these laws must address. However, a notable point in the U.S. proposal is the establishment 164 North American Free Trade Agreement and Labor Rights, supra note 79 165 TPP Chief Negotiators Pleased to Report Continued Progress O FFICE OF THE U NITED S TATES T RADE R EPRES ENTATIVE (December 11, 2012), http://www.ustr.gov/trade agreements/free trade agreements/trans pacific partnership/round 15 newzealand. 166 USTR to push for 12 years of Data Exclusivity for Biologics in TPPA supra note 29 ; Access to Lifesaving Generic Medic ines Threatened by US Trade Pact D OCTORS W ITHOUT B ORDERS (Sep. 8, 2011), http://www.doctorswithoutborders.com/press/release .cfm?id=5519&cat=press release ; Liza Porteus Viana, Special Report : TPP Negotiations To Heat Up In Melbourne Over Patents, Copyright Medicines I NTELLECTUAL P ROPERTY W ATCH (Feb. 21, 2012), http://www.ip watch.org/2012/02/21/special report tpp negotiations to heat up in melbourne over patents copyright medicines/. 167 USTR Tables TPP Labor Proposal that Goes Beyond May 10 Template 130 I NSIDE U.S. T RADE 1, 1 n.1 (Jan. 6, 2012), available at http://www.uscib.org/docs/Inside_ US_Trade_USTR_Tables_TPP_Labor_Proposal_Jan_6_2012.pdf.

PAGE 161

161 pu blic regarding alleged violations of the TPP by other state parties. 168 As this Chapter has shown, FTAs have the potential to have substantial human rights impacts, but the strength of those impacts varies significantly based upon the provisions of those FT As. In negotiating FTAs, state parties should advocate for terms aligned with the ideal terms delineated in this Chapter based upon the human rights impacts of previously enacted FTAs. If the U.S. proposal is adopted as the TPP Labor Chapter, it does have healthy working cond address in their laws and if those laws must not only meet the provisions of the ILO the Occupational Safety and Health Convention, and the Occupational Health Services Convention. 168 Id. at 22.

PAGE 162

162 CHAPTER 6 CONCLUSION In conclusion, it is clear from the foregoing chapters that the rules of free trade offer ample avenues for bolstering practicable access to the right to he alth. However, as seen in Chapters 2 and 5 regarding access to medicine and safe and healthy working conditions, how these rules are structured, such as in FTAs, result in substantially different impacts on access to the right to health. It is the responsi bility of individuals and groups to advocate for (and states to implement) FTAs in the future that build upon the lessons gleaned from the results of previously enacted FTAs by bolstering access to the right to health through less stringent data exclusivit y provisions and requirements for domestic laws related to occupational health. Moreover, it is imperative that states seize the already available opportunities to advance the right to health, including the pr omotion of food fortification, and employ the avenues provided in the SPS Agreement or the TBT Agreement to promote that fort ification (even though i t may limit trade) where circumstances warrant. Yet as seen in Chapter 3 regarding practicable implementation of compulsory licenses, it is also crucia l to ascertain and then develop the necessary conditions for states to be able to truly utilize the opportunities presented in the rules of free trade, such as the flexibilities embedded in TRIPS to advance the right to health. Going forward, future opp ortunities for research include continuing analyses of the human rights impacts of CAFTA it is ratified) Additionally, qualitative analysis could be undertaken regarding the reasons that states do or do not issue compulsory licenses, as well as evaluation of

PAGE 163

163 future issuances of compulsory lic enses and any cases which arise regarding food fortification measures under the SPS Agreement or the TBT Agreement.

PAGE 164

164 REFERENCE LIST Frederick M. A b b o t t The WTO Medici nes Decision: World Pharmaceutical Trade and the Protection of Public Health 99 A M J. I NT L L. 317 (2005). Frederick M. A b b o t t & Jerome H. Reichman The Doha Round's Public Health Legacy: Strategies for the Production and Diffusion of Patented Medicine s under the Amended TRIPS Provisions 10 J I NTL E CON L. 921 n.4 (2007). About Codex C ODEX A LIMENTARIUS C OMMISSION I NTERNATIONAL F OOD S TANDARDS (2012), http://www.codexalimentarius.org/about codex/en/. Access to Lifesaving Generic Medicines Threatened by US Trade Pact, D OCTORS W ITHOUT B ORDERS (Sep. 8, 2011), http://www.doctorswithoutborders.com/press/release.cfm?id=5519&cat=press release. Additional Protocol to the American Convention on Human Rights in the area of Economic, Social, and Cultural Rights: P rotocol of San Salvador, Nov. 14, 1988, 28 I.L.M. 161 [ hereinafter Protocol of San Salvador]. Agreement Between the United States of America and the Hashemite KingdomOf Jordan on the Establishment of a Free Trade Area, 41 I.L.M. 63 (2002) [ hereinafter Jord anian FTA]. Agreement on Technical Barriers to Trade, Apr. 15, 1994, Marrakesh AgreementEstablishing the World Trade Organization, Annex 1A, Legal Instruments -Results of the Uruguay Round,1868 U.NT.S. 120 (entered into force January 1, 1995), available a t http:// www.wto.org/english/docs_e/legal_e/17 tbt_e. htm [ hereinafter TBT Agreement]. Agreement on the Application of Sanitary and Phytosanitary Measures, GATT Doc.MTN/FA II A1A 4 (Dec. 15, 1993) (entered into force January 1, 1995), available at http:// www.wto.org/english/tratop_e/sps_e/spsagr_e.htm#fnt5 [ hereinafter SPS Agreement]. Agreement on Trade Related Aspects of Intellectual Property Rights, Apr. 15, 1994, 33I.L.M. 81 [ hereinafter TRIPS]. L INDSAY A LLAN B RUNO DE B ENOIST O MAR D ARY & R ICHARD H UR RELL ( EDS .), G UIDELINESON F OOD F ORTIFICATION WITH M ICRONUTRIENTS : WHO AND F OOD AND A GRICULTURAL O RGANIZATION OF THE U NITED N ATIONS (2006), available at http://www.who.int/nutrition/publications/guide_food_fortification_micronutrients.p df.

PAGE 165

165 Ambassador Ron Ki rk: "Trade and Access to Medicines: Working to Make the Two Go Hand in Hand O FFICE OF THE U NITED S TATES T RADE R EPRESENTATIVE (July 20, 2012), http://www.ustr.gov/about us/press office/blog/2012/july/ambassador ron kirk trade access medicines. Anemia as a Public Health Problem by Country, Pre school Age Children WHO (2008), http://www.who.int/vmnis/anaemia/prevalence/summary/Pre SAC_anaemia.pdf. At FTA Commission, U.S. Presses Chile On Brand name Drug Protections I NSIDE U.S. T RADE (August 25, 2011), http ://mycommunity.pharm.chula.ac.th/download/news/019/At%20FTA%20Com mission%20U.S.%20Presses%20Chile%20On%20Brand%20Name%20Drug%2 0Protections%20_25%20Aug%2011.pdf. Peter Bailey, The Creation of the Declaration of Human Rights, U NIVERSAL H UMAN R IGHTS N ETWORK h ttp://www.universalrights.net/main/creation.htm (last visited Sep. 23, 2011). Vikas Bajaj & Andrew Pollack, India Orders Bayer to License a Patented Drug N.Y. T IMES (March 12, 2012), http://www.nytimes.com/2012/03/13/business/global/india overrules bay er allowing generic drug.html?src=recg. B ROOK K. B AKER A RTHRITIC F LEXIBILITIES : A NALYSIS OF WTO A CTION R EGARDING P ARAGRAPH 6 OF THE D OHA D ECLARATION ON THE TRIPS A GREEMENT AND P UBLIC H EALTH (2003), available at http://infojustice.org/download/gcongress/ac cess _to_medicines:_tpp,_acta,_and_eu_border_regulation/baker%20article%204.pdf. Reed Beall & Randall Kuhn, Trends in Compulsory Licensing of PharmaceuticalsSince the Doha Declaration: A Database Analysis 9 P LOS 1 n.1 (2012). Berne Convention for the Protection of Literary and Artistic Works, as revised at Paris on July 24, 1971 and amended on September 28, 1979, 828 U.N.T.S. 221. Tina S. Bhatt Amending TRIPS: A New Hope for Increased Access to EssentialMedicines 33 B ROOK J. I NT L L. 597 (2008). James J. Biles Informal Work in Latin America: Competing Perspectives and Recent Debates 3 G EO C OMPASS 214 n.1 (2009). Robert C. Bird, Developing Nations and the Compulsory License: Maximizing Access to Essential Medicines While Minimizing Investment Side Effects 37 J. L AW M ED & E THICS 209 n.2 (2009). Robert Bird & Daniel R. Cahoy, The Impact of Compulsory Licensingon Foreign Direct Investment: A Collective Bargaining Approach 45 A MER B US L. J. 283 n.2 (2008).

PAGE 166

166 Andreas Blthner & Leonie Vierck Setting Standards for Business and Development How legal Frameworks can support market based Nutrition Partnership 4 E URO F EED & F OOD L. R EV 104 n.2 (2009). M ARY J ANE B OLLE J ORDAN U.S. F REE T RADE A GREEMENT : L ABOR I SSUES C.R.S. R EPORT 97 RS20968 (May 27, 2003), available at http://assets.opencrs.com/rpts/RS20968_20030527.pdf. M ARY J ANE B OLLE NAFTA L ABOR S IDE A GREEMENT : L ESSONS FOR THE W ORKER R IGHTS AND F AST T RACK D EBATE C.R.S. R EPORT 97 861 E (Oct. 9, 2001), available at http://fpc.state.gov/d ocuments/organization/6211.pdf. Sarah Boseley Indonesia in bold move to obtain cheap drugs for HIV G UARDIAN (Oct. 11, 2012), http://www.guardian.co.uk/society/sarah boseley global health/2012/oct/11/hiv infection hepatitis b. Kathryn Bromley From Lega l Universalism to Legal Pluralism: Expanding and Enhancing the Human Rights Approach to HIV/AIDS 21 S. A FR J. ON H UM R TS 191 (2005). CAFTA L ABOR R IGHTS R EPORT C OSTA R ICA D OMINICAN R EPUBLIC E L S ALVADOR G UATEMALA H ONDURAS AND N ICARAGUA (June 2005) available at http://www.dol.gov/ilab/media/reports/usfta/DRLaborRights.pdf. CAFTA DR Labor Capacity Building O FFICE OF THE U NITED S TATES T RADE R EPRESENTATIVE (May 2011), http://www.ustr.gov/about us/press office/fact sheets/2011/may/cafta dr labor capac ity building. Cervical Cancer and Latin America, an story of inequality G LOBAL /L ATAM H EALTH AND P HARMA (2011), http://rgenneroriganti.wordpress.com/2011/05/10/cervical cancer and latin america an story of inequality/. Christine A. Chung A Cry for Cheap Protections Create an Ominous Impact on Life Saving Medicines 13 S W J. L. & T RADE A M 171 (2006). A NDREW C LAPHAM & M ARIANO G ARCIA R UBIO T HE O BLIGATIONS OF S TATES WITH R EGARD TO N ON S TATE A CTORS IN THE C ON TEXT OF THE R IGHT TO H EALTH : H EALTH AND H UMAN R IGHTS W ORKING P APER S ERIES N O (2002)), http://www.who.int/hhr/Series_3%20Non State_Actors_Clapham_Rubio.pdf. Codex General Principles for Food Additives 2(a), CODEX STAN 192 1995 (1995, amended 2012). Codex General Principles for the Addition of Essential Nutrients to Food, CAC/GL 09 19 87 (amended 1989, 1991).

PAGE 167

167 Codex Standard for Food Grade Salt, CX Stan 150 1985 (revised 1997, amended 1999, 2001). Alberto R Coll Wielding Human Rights and Constitutional Procedure to Temper the Trade Agreement 33 U. P A J. I NT L L. 461 (2011). Charles T. Collins Chase The Case Against TRIPS Plus Protection in Developing Countries facing AIDS Ep idemics 29 U. P A J. I NT L L. 763 (2008). Commission of the European Communities v. French Republic, C 24/00 (5 Feb. 2004). Commission of the European Communities v Kingdom of Denmark, C 467/98 (5 Nov. 2002). Committee on Economic, Social and Cultural Ri ghts O FFICE OF THE U NITED N ATIONAL H IGH C OMMISSIONER FOR H UMAN R IGHTS http://www2.ohchr.org/english/bodies/cescr/index.htm (last visited Jan 1, 2013). Compulsory Licensing of Efavirenz in Brazil A CCESS TO P HARMACEUTICALS (2010), http://www.accesstopha rmaceuticals.org/case studies in global health/efavirenz brazil/. Rhonda Copelon The Indivisible Framework of International Human Rights: A Sourceof Social Justice in the U.S. 3 N.Y. C ITY L. R EV 59 (1998). C ARLOS M. C ORREA I MPLICATIONS OF THE D OHA D E CLARATION ON THE TRIP S A GREEMENTAND P UBLIC H EALTH : H EALTH E CONOMICS AND D RUG S ERIES EDM N O 12 (2002), http://apps.who.int/medicinedocs/pdf/s2301e/s2301e.pdf. Countries and areas with survey data and regression based estimates: Preschool age children WHO (2008), http://www.who.int/vmnis/vitamina/prevalence/vita_fig2b.pdf. Emily M. Cowley Central American Free Trade Agreement and the International Covenant on Economic, Social, and Cultura l Rights 11 M ICH S T U. J. M ED & L 227 (2007). Data W ORLD B ANK http://data.worldbank.org/about/country classifications/country and lending groups#Upper_middle_income (last visited August 2, 2012).

PAGE 168

168 Data Profile W ORLD B ANK http://web.worldbank.org/W BSITE/EXTERNAL/COUNTRIES/LACEXT/0,,content MDK:22117191~pagePK:146736~piPK:146830~theSitePK:258554,00.html (last visited July 5, 2012); Report for Selected Countries, IMF, http://www.imf.org/external/pubs/ft/weo/2010/02/weodata/weorept.aspx?sy=2010 &ey=2010& scsm=1&ssd=1&sort=country&ds=.&br=1&pr1.x=52&pr1.y=8&c=336 %2C213%2C263%2C268%2C339%2C273%2C218%2C278%2C223%2C283%2 C228%2C288%2C233%2C293%2C238%2C243%2C248%2C366%2C253%2C2 98%2C258%2C299&s=PPPGDP%2CPPPPC&grp=0&a= (last visited July 5, 2012). Fernan do G De Maio Understanding chronic non communicable diseases in Latin America: towards an equity based research agenda 7 G LOBALIZATION & H EALTH 1 (2009), available at http://www.globalizationandhealth.com/content/pdf/1744 8603 7 36.pdf. Declaration on the TRIPS Agreement and Public Health, Nov. 14, 2001, 4th Session, Doha Ministerial Conference, Doc. WT/MIN(01)/DEC/2 [ hereinafter Doha Declaration]. Degree of public health significance of iodine nutrition based on median urinary iodine: 1993 2006 WHO (2008), htt p://www. who.int/vmnis/iodine/status/summary/median_ui_2007_color.pdf. L INDA D ELP M ARISOL A RRIAGA G UADALUPE P ALMA H AYDEE U RITA & A BEL V ALENZUELA S L ABOR S IDE A GREEMENT : F ADING INTO O BLIVION ? A N A SSESSMENT OF W ORKPLACE H EALTH & S AFETY C ASES (UC LA C ENTER FOR L ABOR R ESEARCH AND E DUCATION 2004), available at http://www.labor.ucla.edu/publications/pdf/nafta.pdf. Dominican Republic CDC (February 8, 2011), http://www.cdc.gov/immpact/projects/country/dominicanrepublic.html. Dominican Republic Central America U.S. Free Trade Agreement, May 28, 2004, available at www.ustr.gov/assets/Trade_ Agreements/Regional/ CAFTA/ CAFTA DR_Final_Texts/asset_upload_file934_3935.pdf [ hereinafter CAFTA DR]. Dominican Republic Central America United States Free Trade Agr eement Implementation Act, H.R. Rep. No. 109 182, at 50 (2005), as reprinted in 2005 U.S.C.C.A.N. 337, 344 [ hereinafter Ways and Means Report]. DR CAFTA AND W ORKER S R IGHTS : M OVING FROM P APER TO P RACTICE (Washington Office on Latin America May 18, 2009), a vailable at http://www.strtrade.com/media/publication/911_2009 May 18 wola_dr_cafta_rpt_final.pdf. Graham Dutfield Delivering Drugs to the Poor: Will the TRIPS Amendment Help? 34 A M J. L. & M ED 107 (2008).

PAGE 169

169 Hamed El Said & Mohammed El Said, TRIPS Plu s Implications for Access to Medicines in Developing Countries: Lessons from Jordan United States Free Trade Agreement, 10 J. W ORLD I NTELL P ROPERTY 438 n.6 (2007). Dustin Ensinger Guatemala Says it Will Win Trade Case Against U.S ., E CONOMY IN C RISIS (Se p. 10, 2011), http://economyincrisis.org/content/guatemala says it will win trade case against us. E UROPEAN A GENCY FOR S AFETY AND H EALTH AT W ORK N ATIONAL E CONOMICS AND O CCUPATIONAL S AFETY AND H EALTH (2007), available at https://osha.europa.eu/en/publicat ions/factsheets/76. European Communities EC Measures Concerning Meat and Meat Products AB 1997 4 Report of the Appellate Body, WT/DS26/AB/R, WT/DS48/AB/R (Jan.16, 1998) [ hereinafter EC Hormones]. European Communities Measures Affecting Asbestos and Asbestos Containing Products, WT/DS135/AB/R (12 March 2001) [ hereinafter EC Asbestos]. Filartiga v. Pena Irala 630 F.2d 876 (2d Cir. 1980). Flores v. Southern Peru Copper Corporation 414 F.3d 233 (2d Cir. 2003). F OOD F ORTIFICATION P ROGRAMMES E SPE CIALLY IN D EVELOPING C OUNTRIES (Oct. 27, 2009), http://food fortification.com/Files/Download/Resources/gtz en safo standard setting tool 2009.pdf. Howard Frumkin Free Trade Agreements: Chapter 20 Development, Trade, and Technology in ILO E NCYCLOPEDIA O F O CCUPATIONAL H EALTH AND S AFETY (4 th ed.) (ILO: 1998), available at http://ilocis.org/documents/chpt20e.htm#JD_Figure20.1. Thomas Fuller Thailand takes on drug industry, and may be winning N.Y. T IMES (April 11, 2011), http://www.nytimes.com/2007/04/11/w orld/asia/11iht pharma.4.5240049.html?pagewanted=2&_r=2. General Agreement on Tariffs and Trade 1994, Apr. 15, 1994, Marrakesh Agreement Establishing the World Trade Organization, 33 I.L.M. 1153 (1994) [ hereinafter GATT]. G EORGETOWN H UMAN R IGHTS A CTION / H U MAN R IGHTS I NSTITUTE F ACTFINDING R EPORT (2010), available at http://www.law.georgetown.edu/news/releases/documents/FrequentlyAskedQues tionsDR.pdf. A NTONIO G IUFFRIDA R OBERT F. I UNES & W ILLIAM D. S AVEOFF E CONOMIC AND H EALTH E FFECTS OF O CCUPATIONAL H AZAR DS IN L ATIN A MERICA AND THE C ARIBBEAN (Inter American Development Bank 2001), available at http://idbdocs.iadb.org/wsdocs/getdocument.aspx?docnum=353816.

PAGE 170

170 G LOBAL C OMMISSION ON HIV AND THE L AW : UNDP, R EGIONAL I SSUES B RIEF : I NTELLECTUAL P ROPERTY R IGHTS AND A CCESS TO M EDICINE A SIA P ACIFIC R EGIONAL D IALOGUE (2011), http://www.ippacificislands.org/health/IssuesBrief_IPR.pdf. Global strategy on occupational health for all: The way to health at work WHO (2012), www.who.int/occupational_health/publications/globst rategy/en/index5.html. Roman Grynberg & Veniana Qalo, Labour Standards in US and EU Preferential Trading Arrangements I NTERNATIONAL T RADE AND R EGIONAL C O OPERATION : E CONOMIC A FFAIRS D IVISION M ARLBOROUGH H OUSE P ALL M ALL L ONDON available at http://www.th ecommonwealth.org/Shared_ASP_Files/UploadedFiles/B9B769AA 9547 4CCE 8392 B2CC93E62A3D_LabourStandardsinUSandPreferentialTradeArrangements.pdf (last visited Dec. 8, 2012). Guatemala M ICRONUTRIENT I NITIATIVE http://www.micronutrient.org/ english/view.as p?x=620 (last viewed November 23, 2012). H EALTH S ITUATION IN THE A MERICAS : B ASIC I NDICATORS 7 9 (Pan American Health Organization 2011), available at ais.paho.org/chi/brochures/2011/BI_2011_ENG.pdf. B ERTA E SPERANZA H ERNNDEZ T RUYOL & S TEPHEN J. P OWELL J U ST T RADE : A N EW C OVENANT L INKING T RADE AND H UMAN R IGHTS (2009). Holger P. Hestermeyer, Canadian made Drugs for Rwanda: The First Application of the WTO Waiver on Patents and Medicines 11 ASIL I NSIGHTS 28 (2007), available at http://www.asil.org/insights0 71210.cfm#_edn1 HIV & AIDS in Thailand AVERT, http://www.avert.org/thailand aids hiv.htm (last visited July 4, 2012). HIV/AIDS Prevalence Rates INDEX MUNDI (2011), http://www.indexmundi.com/g/r.aspx?v=32. B ENJAMIN H OLT & M ICHAEL W ALLER I NTERNATIONAL T RADE AND W ORKERS R IGHTS : P RACTICAL T OOLS FOR R EADING L ABOR R IGHTS P ROVISIONS OF F REE T RADE A GREEMENTS (2011), available at http://www.wcl.american.edu/hrbrief/11/3holt.pdf. J.F. H ORNBACK T HE U.S. P ANAMA F REE T RADE A GREEMENT C.R.S. D OC 7 5700, R32540 ( Oct. 27, 2011), available at http://www.fas.org/sgp/crs/row/RL32540.pdf. ICESCR UN T REATY C OLLECTION (Feb. 28, 2012), http://treaties.un.org/Pages/ViewDetails.aspx?src=TREATY&mtdsg_no=IV 3&chapter=4&lang=en.

PAGE 171

171 ILO, 2007 L ABOUR O VERVIEW L ATIN A MERICA AND THE C ARIBBEAN available at http://www.ilo.org/wcmsp5/groups/public/ --americas/ --ro lima/documents/publication/wcms_185221.pdf. ILO, C155 Occupational Safety and Health Convention, 1981 (No. 155), 67th ILC sess. Geneva, (entered into force Aug. 11, 198 3), available at http://www.ilo.org/dyn/normlex/en/f?p=1000:12100:0::NO::P12100_INSTRUMEN T_ID:312300. ILO, C161 Occupational Health Services Convention, 1985 (No. 161), 71st ILC Session Geneva, (entered into force Feb. 17, 1988), available at http://www .ilo.org/dyn/normlex/en/f?p=NORMLEXPUB:12100:0::NO:12100:P121 00_INSTRUMENT_ID:312306:NO. ILO, ILO Declaration on Fundamental Principles and Rights at Work (1998), available at http://www.ilo.org/declaration/thedeclaration/textdeclaration/lang -en/index.ht m. ILO, P155 Protocol of 2002 to the Occupational Safety and Health Convention art. 1(a b), 1981, available at http://www.ilo.org/dyn/normlex/en/f?p=NORMLEXPUB:55:0:::55:P55_TYPE,P55 _LANG,P55_DOCUMENT,P55_NODE:SUP,en,P155,/Document [ hereinafter Protocol of 2002]. Implementation of Paragraph 6 of the Doha Declaration on the TRIPS Agreement andPublic Health, Decision of 30 August 2002, Doc. WT/L/540 (entered into force Sep. 2, 2003) [ hereinafter Paragraph 6 Decision]. Industrial Property Registry, Patent Office Costa Rica WIPO, http://www.wipo.int/scp/en/exceptions/replies/costa_rica.html#Q9 (last visited July 5, 2012). International Covenant for Economic, Social, and Cultural Rights, Dec. 16, 1966, 993U.N.T.S. 3 [ hereinafter ICESCR]. Joint FAO/WHO Food S tandards Programme: Codex Alimentarius Commission, 23d Sess., Report of the Forty fifth Sess. of the Exec. Comm. of the Codex Alimentarius Commission, ALINORM 99/33, June 5, 1998 [ hereinafter 1998 CAC Executive Committee Session]. Mara F. Jorge The Per uvian implementation of the US Peru FTA: A model for the world with room for improvement 7 J. G ENERIC M ED 40 n.1 (2010). Kate E. Kaiser, The Fight for Access to AIDS Medications: How the Central American Constitutional Courts 25 W IS I NT L L.J. 535 (2007). W ARREN K APLAN AND R ICHARD L AING H EALTH N UTRITION AND P OPULATION D ISCUSSION P APER : L OCAL P RODUCTION OF P HARMACEUTICALS : I NDUSTRIAL P OLICY AND A CCESS

PAGE 172

172 TO M EDICINES A N O VERVIEW OF K EY C ONCEPTS I SSUES AND O PPORTUNITIES FOR F UTURE R ESEARCH 10 1 (J an. 2005), available at http://www.who.int /medicines/technical_briefing/tbs/KaplanLocalProductionFinal5b15d.pdf. Vanessa Bradford Kerry & Kelley Lee, TRIPS, the Doha declaration and Paragraph 6 Decision: what are the remaining steps for protecting access to medicines? ,3 G LOBAL H EALTH 1 n.3 (2007). Eleanor D. Kinney The International Human Right to Health: What Does This Mean forour Nation and World 34 I ND L. R EV 1457 (2001). K IRK S OLIS L ETTER TO G UATEMALA ABOUT L ABOR R IGHTS V IOLATIONS (July 30, 2010), available at http://www.ustr.gov/webfm_send/2114. Jakkrit Kuanpoth Give the poor patients a chance: enhancing access to essential medicines through compulsory licensing 6 J. OF G ENERIC M ED 15 n.1 (2008). Latin America: Compulsory Licensing Becomes Sexy M ANAGING I NTELLECTUAL P ROPERTY (April 1, 2002), http://www.managingip.com/Article/1321873/Latin AmericaCompulsory licensing becomes sexy.html. D EMOCRACY D IGEST (Augu st 14, 2012), http://www.demdigest.net/blog/2012/08/latin americas inclusive middle class/. L ETTER TO USTR R ON K IRK FROM F IVE M EMBERS OF C ONGRESS (September 8, 2011), available at http://infojustice.org/wp content/uploads/2011/09/Five MOCs September 8 2011 .pdf. L ETTER TO USTR R ON K IRK FROM T EN M EMBERS OF C ONGRESS (August 2, 2011), available at http://infojustice.org/wp content/uploads/2011/08/Ten Representatives on TPP 08022011.pdf. Kristina M. Lybecker & Elisabeth Fowler, Compulsory Licensing in Canada an d Thailand: Comparing Regimes to Ensure Legitimate Use of the WTO Rules 37 J. OF L AW M ED & E THICS 222 n. 2 (2009). Malnutrition costs Latin America billions of dollars per year A LERTNET ( Oct. 15, 2009),http://www.trust.org/alertnet/news/malnutrition c osts latin america billions of dollars per year/. Rohit Malpani All costs, no benefits: How the US Jordan free trade agreement affects access to medicines 6 J. G ENERIC M ED 206 n.3 (2009). R UTH M AYNE R EGIONALISM B ILATERALISM AND THE P LUS A G REEMENTS : T HE T HREAT THE D EVELOPING C OUNTRIES : H UMAN D EVELOPMENT R EPORT 2005 available at http://hdr.undp org/en/reports/global/hdr2005/papers/HDR2005_Mayne_Ruth_18.pdf.

PAGE 173

173 Members accepting amendment of the TRIPS Agreement WTO (Jan. 5, 2012), http://www.w to.org/english/tratop_e/TRIPS_e/amendment_e.htm. Mercurio, Bryan Resolving the Public Health Crisis in the Developing World: Problems and Barriers of Access to Essential Medicines 5 N W J. OF I NTL H UM R 1 n.1 (2006). Minister of Health v. Treatment Act ion Campaign Constitutional Court of South Africa, CCT 8/02 (2002). Winston P. Nagan Human Rights, Liberty & Socio Economic Justice: Economic Theoryand the Ascent of Private Property Values, 1 C ADMUS 1 n.2 (2011). R OSE N ATHAN F OOD F ORTIFICATION R EGULA TION I N L IGHT OF THE WTO A GREEMENTS (2012), available at http://ebookbrowse.com/wto and food fortification regulation rn english pdf d287639547. N ON C OMMUNICABLE C HRONIC D ISEASES I N L ATIN A MERICA AND THE C ARIBBEAN (Bloomberg School of Public Health & USAID 2009), available at http://www.healthycaribbean.org/publications/documents/NCD in LAC USAID.pdf. North American Agreement on Labor Cooperation, Can. Mex. U.S., Annex 1, Sept. 14, 1993, 32 I.L.M. 1499, 1515 [ hereinafter NAALC]. North American Free Trade Ag reement and Labor Rights I NTERNATIONAL L ABOR R IGHTS F UND (1995), http://www.iatp.org/files/North_American_Free_Trade _Agreement_and_Labor_.htm. Ruth L. Okediji WIPO WTO Relations and the Future of Global Intellectual Property Norms 5 (2009) (Minnesota Legal Studies Research Paper No. 09 07), available at http://papers.ssrn.com/sol3/papers.cfm?abstract_id=1338902. Maria Auxiliadora Oliveira Jorge Antonio Zepeda Bermudez, Gabriela Costa Chaves, & Germn Velsquez, Has the implementation of the TRIPS A greement in Latin America and the Caribbean produced intellectual property legislation that favours public health? 82 B ULL OF W ORLD H EALTH O RG 815 n.11 (2004). Optional Protocol to the ICESCR UN T REATY C OLLECTION (Feb. 2, 2013), http://treaties.un.org/ Pages/ViewDetails.aspx?src=TREATY&mtdsg_no=IV 3 a&chapter=4&lang=en.. The Paquete Habana 175 U.S. 677 (1900). Parallel Imports and Border Measures in DR/CAFTA M ANAGING I NTELLECTUAL P ROPERTY (May 1, 2009), http://www.managingip.com/Article/2192547/Para llel imports and border measures in DRCAFTA.html.

PAGE 174

174 Sapna Parikh Chagas disease most important infection never heard about ABC (May 31, 2012), http://abclocal.go.com/wabc/story?section=news/health&id=8684001. Paris Convention for the Protection of Industr ial Property, as last revised at the Stockholm Revision Conference, July 14, 1967, 828 U.N.T.S. 303 [ hereinafter Paris Convention]. Paschim banga Khet Samity v. State of West Bengal, Supreme Court of India Case No. 169, 4 SCC 37 (1996). Patent Cooperation Treaty ("PCT") (1970) PCT,http://www.wipo.int/pct/en/treaty/about.html (last visited Feb. 16, 2013). PCT, P ATENT L ENS http://www.patentlens.net/daisy/KeyOrgs/1236/418/420/422.html (last visited Feb. 16, 2013). Luke Eric Peterson CAFTA Labour Arbitrat ion Should Play Out on Fast Track K LUWER A RBITRATION B LOG (August 15, 2011), http://kluwerarbitrationblog.com/blog/2011/08/15/cafta labour arbitration should play out on fast track/. Rodrigo Pizarro The Free Trade Agreement between the USA and Chile: An Instrument of U.S. Commercial Interests T HE I DEAS W ORKING P APER S ERIES P APER N O 02/2006 (2006), available at http://www.networkideas.org/working/oct2006/02_2006.pdf. Sandra Polaski Protecting Labor Rights through Trade Agreements: An Analytical Guid e 10 U.C D AVIS J. I NT L L. & P OL Y 13 (2003). Carlos Ponce Current situation of Chagas disease in Central America 102 R IO DE J ANEIRO 41 (Suppl. I 2007). K RISHNA P RABHU & E RIC C ERVINI WHO C OMPULSORY L ICENSING : H ARVARD M ODEL C ONGRESS A SIA 2012 3, ava ilable at http://hmcasia.org/wp content/uploads/2011/05/WHO_Compulsory Licensing.pdf. HIV & AIDS in Thailand, AVERT, http://www.avert.org/thailand aids hiv.htm (last visited July 4, 2012). Praise for Ecuador's grant of compulsory license for AIDS drug P E OPLE S H EALTH M OVEMENT (May 4, 2010), http://www.phmovement.org/en/node/2883. Charles B. Rangel, Moving Forward: A New Bipartisan Trade Policy that Reflects American Values 45 H ARV J. ON L EGIS 377 (2008). Ratifications of C155 Occupational Safety and Health Convention, 1981 (No. 155) ILO (2012), http://www.ilo.org/dyn/normlex/en/f?p=1000:11300:0::NO:11300:P11300_INSTR UMENT_ID:312300; Ratifications of P155 Protocol of 2002 to the Occupational

PAGE 175

175 Safety and Health Convention, 1981, ILO (2012), http://ww w.ilo.org/dyn/normlex/en/f?p= NORMLEXPUB:11300:0::NO:11300:P11300_INSTRUMENT_ID:312338:NO. Ratifications of C161 Occupational Health Services Convention, 1985 (No. 161) ILO (2012), http://www.ilo.org/dyn/normlex/en/f?p=1000:11300:0::NO:11300:P11300_IN STR UMENT_ID:312306. Jerome H. Reichman, Compulsory licensing of patented pharmaceutical inventions:evaluating the options 37 J. L AW M ED & E THICS 247 n.2 (2009). P EDRO R OFFE TRIPS I SSUE P APER 4: B ILATERAL A GREEMENTS AND A TRIPS PLUS WORLD : THE C HILE USA F REE T RADE A GREEMENT (2004), available at http://www.quno.org/geneva/pdf/economic/Issues/Bilateral Agreements and TRIPS plus English.pdf. Catherine Saez Ecuador Grants First Compulsory Licence For HIV/AIDS Drug, I NTELL P ROP W ATCH (April 22, 2010 ), http://www.ip watch.org/2010/04/22/ecuador grants first compulsory licence for hivaids drug/. Jeremy Sarkin & Mark Koenig, Developing the Right to Work: Intersecting and Dialoguing Human Rights and Economic Policy 33 H UM R TS Q. 1 (2011). Susan K. Sell, TRIPS Plus Free Trade Agreements and Access to Medicine 28 L IVERPOOL L. R EV 41 (2007). Jos Serra, Minister of Health of Brazil, Keynote address at AIDS 20 Years Later: An International Health Conference: Lessons from the Brazilian AIDS Program, ( 2001). Ellen R. Shaffer & Joseph E. Brenner, Generic Drugs 28 H EALTH A FF 957 n.5 (2009). Ellen Shaffer Joseph Brenner & Shayna Lewis, CAFTA: Barriers to Access to Medicine in Guatemala H EALTH AND H UMAN R IGHTS (Nov. 23, 2009), http://www.hhropenforum.org/2009/11/cafta barriers to access to medicines in guatemala/. L EJ O S IBBEL T HE L ABOUR P ROVISIONS IN THE U.S. J ORDAN F REE T RADE A GREEMENT : I MPACT AND L ESSONS L EARNT 7 (April 26, 2010), available at http://www.a mericanbar.org/content/dam/aba/administrative/labor_law/meetings/ 2010/2010_intl_sibbel.authcheckdam.pdf. Status of Submissions under the NAALC U.S. D EPARTMENT OF L ABOR http://www.dol.gov/ilab/programs/nao/status.htm#.UMzkV3ewWSo (last viewed Dec. 15, 20 12).

PAGE 176

176 Paulette L. Stenzel Free Trade and Sustainability through the Lens of Nicaragua: How CAFTA should be Amended to Promote the Triple Bottom Line 34 W M & M ARY E NVTL L. & P OL Y R EV 653 (2010). C ASSANDRA S WEET & A NDREA L APLANE ECLAC, T HE L ATIN A M ERICAN P HARMACEUTICAL S ECTOR : L EGAL AND C OMMERCIAL T RENDS IN THE P OST TRIPS E NVIRONMENT (2010), available at http://ictsd.org/downloads/2010/03/sweet laplane presentation.pdf. Yves Cozien Papa Tchofou, Compulsory Licensing and Access to Medicines in the TRI PS compliant World: Policy Options for Anti HIV Drugs in Sub Sahara Africa 55 (2011) (M.A. thesis, Hanken School of Economics), available at https://helda.helsinki.fi/bitstream/handle/10138/25952/papa.pdf;jsessionid=9B068 FF89DC92076FBCEE58DC654433B?sequenc e=1. Sharon Thach & Susan J. Marsnik, Patent Standards Under TRIPS and the Pharmaceutical Industries in Brazil and India 10 L ATIN R EV 237 n.4 (2009). T OGETHER W E W ILL E ND AIDS (UNAIDS 2012), available at http://www.unaids.org/en/media/unaids/contenta ssets/documents/epidemiology/2 012/JC2296_UNAIDS_TogetherReport_2012_en.pdf. T OPIC 10: T HE U SE OF C OMPULSORY L ICENSES (CL), R EGIONAL S EMINAR FOR C ERTAIN L ATIN A MERICAN AND C ARIBBEAN C OUNTRIES ON THE I MPLEMENTATION AND U SE OF S EVERAL P ATENT R ELATED F LEXIBILI TIES 17 (2012), http://www.wipo.int/edocs/mdocs/mdocs/en/ wipo_ip_bog_12/wipo_ip_bog_12_ref_u10c_binsfeld.pdf. TPP Chief Negotiators Pleased to Report Continued Progress O FFICE OF THE U.S. T RADE R EPRESENTATIVE (December 11, 2012), http://www.ustr.gov/tra de agreements/free trade agreements/trans pacific partnership/round 15 newzealand. C ITIZEN S T RADE C AMPAIGN (March 2012), http://www.citizenstrade.org/ctc/wp content/uploads/2012/03/TransPacificPublicHealth.pdf. Trainin g in Environmental health to Reduce Chronic Diseases in Latin America M OUNT S INAI S CHOOL OF M EDICINE (2012), www.mssm.edu/research/programs/mount sinai global health/education/reducing chronic diseases. G EORGE T SAI C ANADA S A CCESS TO M EDICINES R EGIME : L ESSONS FOR C OMPULSORY L ICENSING S CHEMES UNDER THE WTO D OHA D ECLARATION available at http://accesstomedicineseminar.files.wordpress.com/2010/01/canada_s access to medicine_s regime2.pdf.

PAGE 177

177 U.N. Econ. & Soc. Council, Comm. on Econ., Soc. and Cultural Rights, General Comment No. 12: The Right to Adequate Food, U.N. Doc. E/C.12/1999/5 (May 12, 1999) [ hereinafter ICESCR General Comment 12]. U.N. Econ. & Soc. Council, Comm. on Econ., Soc. and Cultural Rights, GeneralComment No. 14: The Right to the Highest Attaina ble Standard of Health, U.N. Doc. E/C. 12/2000/4 (Aug. 11, 2000) [hereinafter ICESCR General Comment 14]. U.N. Econ. & Soc. Council, Comm. on Econ., Soc. and Cultural Rights, General Comment No. 18: The Right to Work, U.N. Doc. E/C.12/GC/18 (Feb. 6, 2006 ) [ hereinafter ICESCR General Comment 18]. U.N. Charter preamble. United States Chile Free Trade Agreement, U.S. Chile, Jan. 1, 2004, available at www.ustr.gov/assets/Trade_ Agreements/Bilateral/Chile_FTA/Final_Texts /asset_upload_file912_4011.pdf [ herein after Chilean FTA]. United States Colombia Trade Promotion Agreement, U.S. Colom., Nov. 22, 2006 (entered into force May 15, 2012), available at http://www.ustr.gov/trade agreements/free trade agreements/colombia fta/final text [ hereinafter U.S. Colombia F TA]. United States Panama Trade Promotion Agreement, U.S. Panama, June 28, 2007, (entered into force Oct. 31, 2012), available at http://www.ustr.gov/trade agreements/free trade agreements/panama tpa/final text [ hereinafter U.S. Panama FTA]. United States Peru Trade Promotion Agreement, U.S. Peru, Apr. 12, 2006 (entered into force Feb. 1, 2009), available at http://www.ustr.gov/trade agreements/free trade agreements/peru tpa/final text [ hereinafter U.S. Peru FTA]. The Universal Declaration of Human Rights, G.A. Res. 217, U.N. GAOR, 3d Sess., U.N.Doc. A/810 (1948) [ hereinafter UDHR]. U.S. Chile Free Trade Agreement C ITIZENS T RADE C AMPAIGN http://www.citizenstrade.org/ctc/trade policies/existing trade agreements/other bilateral trade agreements/u s chile f ree trade agreement/. U.S. Restrictions on Imports of Tuna II, DS29/R (16 June 1994).

PAGE 178

178 U.S. Trade Representative Ron Kirk Announces Next Step in Labor Rights Enforcement Case against Guatemala O FFICE OF THE U NITED S TATES T RADE R EPRESENTATIVE (August 9, 2 011), http://www.ustr.gov/about us/press office/press releases/2011/august/us trade representative ron kirk announces next ste. USTR Tables TPP Labor Proposal that Goes Beyond May 10 Template 130 I NSIDE U.S. T RADE 1 n.1 (Jan. 6, 2012), available at http: //www.uscib.org/docs/Inside_US_Trade_USTR_Tables_TPP_Labor_Propos al_Jan_6_2012.pdf. USTR to push for 12 years of Data Exclusivity for Biologics in TPPA I NSIDE U.S. T RADE (May 30, 2011), http://donttradeourlivesaway.wordpress.com/2011/05/30/ustr to push f or 12 years of data exclusivity for biologics in tppa/. Utilizing TRIPS Flexibilities for Public Health Protection Through South South Regional Frameworks WHO (2004), http://apps.who.int/medicinedocs/en/d/Js4968e/6.1.5.html#Js4968e.6.1.5. Liza Port eus Viana Special Report : TPP Negotiations To Heat Up In Melbourne Over Patents, Copyright, Medicines I NTELLECTUAL P ROPERTY W ATCH (Feb. 21, 2012), http://www.ip watch.org/2012/02/21/special report tpp negotiations to heat up in melbourne over patents copyright medicines/. Vienna Convention on the Law of Treaties, May 23, 1969, 1155 U.N.T.S. 331. V IERCK L EONIE F OOD F ORTIFICATION : GTZ/SAFO S TANDARD S ETTING T OOL FOR N ATIONAL Simon Walker, The United States Dominican Republic Central American Free Trade Agreemen t and Access to Medicines in Costa Rica: A Human Rights Impact Assessment, 3 J H UM R TS P RAC 188 n.2 (2011). Henry A. Waxman Agreement I NFO J USTICE (May 15, 2012), http://infojustice.org/a rchives/23270. Ashley Weber & Lisa Mills, A one time only combination: Emergency medicine exports 12 H EALTH AND H UM R TS 109 n.1 (2010). Marley S. Weiss Two Steps Forward, One Step Back Or Vice Versa: Labo r Rights Under Free Trade Agreements From NAFTA through Jordan, via Chile, to Latin America, and Beyond 37 U.S.F. L. R EV 689 (2003). WHO, C OUNTRY E XPERIENCES IN USING TRIPS S AFEGUARDS 3 (2008), available at http://www.searo.who.int/LinkFiles/IPT_Briefin g_note_4_country_experiences.pdf Centres for Occupational Health Stresa, Italy, (June 8 9, 2006), available at http://www.who.int/occupational_health/Declarwh.pdf.

PAGE 179

179 WHO Model Li sts of Essential Medicines WHO, March 2011, http://www.who.int/medicines/publications/essentialmedicines/en. WHO M ODEL L IST OF E SSENTIAL M EDICINES (2011), http://whqlibdoc.who.int/hq/2011/a95053_eng.pdf. W ORLD H EALTH O RGANIZATION AND W ORLD T RADE O RGANIZA TION WTO A GREEMENTS & P UBLIC H EALTH (2002), available at http://www.wto.org/english/res_e/booksp_e/who_wto_e.pdf. WTO, Amendment of the TRIPS Agreement, WT/L/641 (Dec. 8, 2005), available at http://www.wto.org/english/tratop_ e/TRIPS_e/wt1641_e.htmT/L/64 1 [ hereinafter TRIPS Amendment]. T HE WTO D ECISION ON C OMPULSORY L ICENSING K OMMERSKOLLEGIUM : S WEDISH N ATIONAL B OARD OF T RADE 37 (2008), available at http://www.kommers.se/upload/Analysarkiv/Arbetsomr%C3%A5den/WTO/Handel %20och%20skydd%20f%C3%B6r%20immateri ella%20r%C3%A4ttigheter%20 %20TRIPS/Rapport%20The_WTO_decision_on_compulsory_licensing.pdf. WTO rules and environmental policies: GATT exception WTO (2012), http://www.wto.org/english/tratop_e/envir_e/envt_rules_exceptions_e.htm. Years of Potential Life L ost N ATIONAL A SSOCIATION FOR P UBLIC H EALTH S TATISTICS http://www.naphsis.org/Documents/YPLL.pdf. Yun Ching Yeh Pharmaceutical Data Protection Law and Policy and Their Effects on the Right to Medicines: a Comparative Analysis 148 (2009) (dissertation, Golden Gate University School of Law), available at http://digitalcommons.law.ggu.edu/theses/25.

PAGE 180

180 BIOGRAPHICAL SKETCH Dominique Lochridge Gonzales graduated summa cum laude with a Bachelor of Arts in economics and certificate in international relat ions from the University of Florida in 2007. Throughout her undergraduate studies, she became increasingly interested in international trade and thus chose to pursue a Masters of Arts in international business (with a minor in fo od and resource economics) at the University of Florida in 2007. During that program, she traveled to Brazil for the International Financial Markets Study Tour which sparked her interest in economic development in Latin America. Knowing that she desired a career in which she could h elp promote economic joint degree in law and Latin American studies in 2009 and plans to graduate with both degrees in May 2013.