Access to information and the right to health: The human rights case for clinical trials transparency

American Journal of Law and Medicine

Volumn 38, Issue 1, 2012, Pages 63-112

  Lemmens, Trudo ^a   Telfer, Candice ^b  

^a UNIVERSITY OF TORONTO   (Canada)

^b Ministry of the Attorney General of Ontario   (Canada)

Author keywords

[No Author keywords available]

Indexed keywords

ACCESS TO INFORMATION; ARTICLE; CLINICAL TRIAL (TOPIC); EPIDEMIOLOGY; ETHICS; HUMAN; HUMAN RIGHTS; LEGAL ASPECT; PRODUCT SAFETY; PUBLIC HEALTH; REGISTER;

ACCESS TO INFORMATION; BIAS (EPIDEMIOLOGY); CLINICAL TRIALS AS TOPIC; CONSUMER PRODUCT SAFETY; HUMAN RIGHTS; HUMANS; PUBLIC HEALTH; REGISTRIES;

EID: 84861664953     PISSN: 00988588     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (244)

1. See Paige E. Goodwin, Right Idea, Wrong Result - Canada's Access to Medicines Regime, 34 AVM. J. L. & MED. 567, 583 (2008)
2. (citing Stephen Lewis, U. N. Secretary General's Special Envoy for HIV/AIDS (Sept. 25, 2003)) ("I want to emphasize that there is absolutely nothing standing in the way of such an initiative except a paralysis of political will and the influence of the big pharmaceutical companies.").
3. See Abbott M. Frederick, The Doha Declaration on the TRIPS Agreement and Public Health: Lighting a Dark Corner at the WTO, 5 J. INT'L ECON. L. 469, 495 (2002);
4. see also CARLOS M. CORREA, INTELLECTUAL PROPERTY RIGHTS, THE WTO AND DEVELOPING COUNTRIES: THE TRIPS AGREEMENT AND POLICY OPTIONS 88 (2000).
5. For example, in the context of HIV/AIDS medicines, see The Minister of Health v. Treatment Action Campaign (TAC) 2002 (5) SA 721 (CC)
6. (S. Afr.), Glenda Lopez v. Instituto Venezolano de Seguras Sociales 487-060401 (Venezuela), Cruz del Valle Bermudez y otros v. MSAS, and Asociacion Benhalensis y otros v. Ministerio de Salud y Accion Social, 323 Fallos 1339 (2000).
7. See also Soobramoney v. Minister of Health (Kwazulu-Natal) 2002 (1) (SA) (CC) 32/97 (S. Afr.).
8. The Canadian Supreme Court has found, in an otherwise controversial decision, that access to therapies in the context of wait times is a component of the right to life. Chaoulli v. Quebec (Attorney General), [2005] 1 S. C. R. 791 (Can.).
9. See Judit Rius Sanjuan, James Love & Robert Weissman, Protection of Pharmaceutical Test Data: A Policy Proposal, CONSUMER PROJECT ON TECH. (2006), available at http://www.cptech.org/ip/health/data/CPTech-Test-Data.pdf;
10. see also Judit Rius Sanjuan et al., A Cost Sharing Model to Protect Investments in Pharmaceutical Test Data, CONSUMER PROJECT ON TECH. (2006), available at http://www.cptech.org/publications/policybrief-nol-cost-sharing. pdf.
11. Agreement on Trade-Related Aspects of Intellectual Property Rights, Apr. 15, 1994
12. Marrakesh Agreement Establishing the World Trade Organization, Annex 1C, in THE LEGAL TEXTS: THE RESULTS OF THE URUGUAY ROUND OF MULTILATERAL TRADE NEGOTIATIONS 320(1999), 1869
13. U. N. T. S. 299
14. -33 I. L. M. 1197 (1994) [hereinafter TRIPS Agreement]. For a list of relevant bilateral trade agreements
15. see A Survey of Data Exclusivity Legislations, EXPRESS PHARMA PULSE, http://www.expresspharmaonline.com/20021121/oped.shtm! (last visited Jan. 29, 2012).
16. For a solid recent discussion of this issue, see Joanna Erdman, Access to Information on Safe Abortion: A Harm Reduction and Human Rights Approach, 34 HARV. J. L. & GENDER 413 (2011).
17. For a similar claim, see a short paper by Rodrigo Salinas, Open Access to Research Protocols and Results: Intellectual Property and the Right to Health, in 4 GLOBAL FORUM UPDATE ON RESEARCH FOR HEALTH: EQUITABLE ACCESS: RESEARCH CHALLENGES FOR HEALTH IN DEVELOPING COUNTRIES 47-48 (2007).
18. See, e.g., Tracy R. Lewis, Jerome H. Reichman & Anthony D. So, The Case for Public Funding and Oversight of Clinical Trials, ECONOMISTS' VOICE (2007), available at http://www.bepress.com/ev/vol4/issl/art3/;
19. see also Jerome H. Reichman, Rethinking the Role of Clinical Trial Data in International Intellectual Property Law: The Case for a Public Goods Approach, 13 MARQ. INTELL. PROP. L. REV. 1 (2009). The "public good" approach also seems to be embraced by reports of the Knowledge Ecology International. See, in particular, Sanjuan, Love & Weissman, supra note 4, and Sanjuan et al., supra note 4.
20. see also Alex J. London, Jonathan Kimmelman & Marina E. Emborg, Beyond Access vs. Protection in Trials of Innovative Therapies, 328 SCI. 829 (2010) (suggesting that preclinical research can be considered a social good).
21. See, e.g., SHELDON K. RIMSKY, SCIENCE IN THE PRIVATE INTEREST: HAS THE LURE OF PROFIT CORRUPTED BIOMEDICAL RESEARCH? 229 (2003);
22. Wayne A. Ray & C. Michael Stein, Reform of Drug Regulation - Beyond an Independent Drug-Safety Board, 354 NEW ENG. J. MED. 194 (2006);
23. MARCIA ANGELL, THE TRUTH ABOUT THE DRUG COMPANIES: HOW THEY DECEIVE US AND WHAT TO DO ABOUT IT (2004). In an earlier publication, one of us supported these recommendations, without using
24. See Trudo Lemmens, Leopards in the Temple: Restoring Scientific Integrity to the Commercialized Research Scene, 32 J. L. MED. & ETHICS 641, 652-653 (2004).
25. see Karmela Krleža-Jerié et al., Prospective Registration and Results Disclosure of Clinical Trials in the Americas: A Roadmap Towards Transparency, 30 PANAM. J. PUB. HEALTH 87 (2011)
26. [hereinafter Krleža-Jerić et al., Prospective Registration].
27. See Kay Dickersin & Drummond Rennie, Registering Clinical Trials, 290 JAMA 516 (2003) (detailing the history of trial registration).
28. See Iain Chalmers et al., The Oxford Database of Perinatal Trials: Developing a Register of Published Reports of Controlled Trials, 7 CONTROLLED CLINICAL TRIALS 306 (1986);
29. Kay Dickersin, Report from the Panel on the Case for Registers of Clinical Trials at the Eighth Annual Meeting of the Society for Clinical Trials, 9 CONTROLLED CLINICAL TRIALS 76 (1988);
30. Curtis L. Meinert, Toward Prospective Registration of Clinical Trials, 9 CONTROLLED CLINICAL TRIALS 1 (1988).
31. See R. J. Simes, Publication Bias: The Case for an International Registry of Clinical Trials, 4 J. CLINICAL ONCOLOGY 1529 (1986).
32. See, e.g., FOOD & DRUG ADMIN., U. S. DEP'T OF HEALTH & HUMAN SERVS., Guidance for Industry: Information Program on Clinical Trials for Serious or Life-Threatening Diseases 2-3(2002), available at http://www.fda.gov/downloads/RegulatoryInformation/Guidances/ucml26838.pdf.
33. Health Omnibus Programs Extension of 1988, 42 U. S. C. § 201 (1988).
34. Food and Drug Administration Modernization Act of 1997, 21 U. S. C. § 301 (2006).
35. Drummond Rennie suggests this case in particular made trial registration an "irresistible" idea. Drummond Rennie, Trial Registration. A Great Idea Switches from Ignored to Irresistible, 292 JAMA 1359, 1359 (2004). For a detailed discussion of one of the controversial studies involved and the selective publication practices
36. see Jon N. Jureidini, Leemon B. McHenry & Peter R. Mansfield, Clinical Trials and Drug Promotion: Selective Reporting of Study 329, 20 INT'L J. RISK & SAFETY MED. 73 (2008).
37. See New York v. GlaxoSmithKline, No. 04-CV-5304 MGC, 2004 WL 1932763 (S. D. N. Y. Aug. 26, 2004).
38. Richard Horton, Vioxx, the Implosion of Merck and Aftershocks at the FDA, 364 THE LANCET 1595 (2004);
39. Eric J. Topol, Failing the Public Health - Rofecoxib, Merck, and the FDA, 351 NEW ENG. J. MED. 1707 (2004).
40. See Joseph S. Ross et al., Guest Authorship and Ghostwriting in Publications Related to Rofecoxib: A Case Study of Industry Documents From Rofecoxib Litigation, 299 JAMA 1800, 1800 (2008);
41. Bruce M. Psaty & Richard A. Kronmal, Reporting Mortality Findings in Trials of Rofecoxib for Alzheimer Disease or Cognitive Impairment: A Case Study Based on Documents From Rofecoxib Litigation, 299 JAMA 1813, 1813 (2008).
42. *2.
43. See Davina Ghersi & Tikki Pang, From Mexico to Mali: Four Years in the History of Clinical Trial Registration, 2 J. EVIDENCE-BASED Med. 1 (2009). An important early initiative was the development of the Current Controlled Trials web site, which includes a meta-register of clinical trials registered on four different continents and the International Standard Randomized Controlled Trial Number system.
44. See Frequently Asked Questions, CURRENT CONTROLLED TRIALS (June 2009), http://www.controlled-trials.com/information/faqs.asp.
45. The Ministerial Summit on Health Research, Mexico City, Mex., Nov. 16-20, 2004, The Mexico Statement on Health Research, Knowledge for Better Health: Strengthening Health Systems 3 (Nov. 16-20, 2004), available at http://www.who.int/rpc/summit/agenda/en/mexico-statement-on-health-research.pdf;
46. see also WORLD HEALTH ASSEMBLY, WHA58J4: Ministerial Summit on Health Research, WORLD HEALTH ORG., available at http://apps.who.int/gb/ebwha/pdf- files/WHA58/WHA58-34-en.pdf.
47. See About Registries, WORLD HEALTH ORG., http://www.who.int/ictrp/ network/trds/en/index.html (last visited Dec. 24, 2011).
48. See, e.g., Karmela Krleža-Jerié, Clinical Trial Registration: The Differing Views of Industry, the WHO, and the Ottawa Group, 2 PLoS MED. e378 1093, 1095 (2005) [hereinafter Krleža-Jerié, Clinical Trial Registration];
49. Karmela Krleža-Jerié, Draft - The Ottawa Statement, Part Two: Principles of Operationalisation for International Trial Registration, OTTAWA GROUP (Jan. 6, 2006), available at http://ottawagroup. ohri.ca/docs/draft-Ottawa-Statement-Part2.pdf [hereinafter Krleza-Jerte, Draft-The Ottawa Statement]. For the first most influential consensus statement on trial registration and results reporting of the Ottawa Group
50. see Karmela Krleža-Jerić et al., Principles for International Registration of Protocol Information and Results from Human Trials of Health Related Interventions: Ottawa Statement (part 1) 330 BRIT. MED. J. 956 (2005) [hereinafter Krleža-Jerić et al., Principles for International Registration].
51. For a list of the signatories, see Ottawa Hospital Research Institute, Group Signatories, OTTAWA STATEMENT ON TRIAL REGISTRATION, http://ottawagroup. ohri.ca/signatories.html (last visited Jan. 29, 2012).
52. Krleža-Jerić, Draft - The Ottawa Statement, supra note 32.
53. Pan American Health Organization [PAHO], 49th Directing Council, 61st Session of the Regional Committee of WHO for the Americas, Policy on Research for Health, at 10, PAHO Doc. CD49/10 (July 10, 2009), available at http://new.paho.org/hq/dmdocuments/2009/CD49-10-e.pdf.
54. See About Registries: Primary Registries in the WHO Registry Network, WORLD HEALTH ORG., http://www.who.int/ictrp/network/primary/en/index.html (last visited Dec. 25, 2011).
55. For information on the International Conference of Medical Journal Organization, see INT'L CONFERENCE OF MED. JOURNAL ORG., http://www.icmje.org (last visited Dec. 25, 2011).
56. See Krleža-Jeric et al., Prospective Registration, supra note 11, at 91-94.
57. World Medical Association General Assembly, WMA Declaration of Helsinki - Ethical Principles for Medical Research Involving Human Subjects, WORLD MED. ASS'N, http://www.wma.net/en/30publications/10policies/b3/ (last visited Dec. 25, 2011).
58. See Food and Drug Administration Amendments Act of 2007, Pub. L. No. 110-85, § 801, 121 Stat. 823, 904-22 (2007).
59. Eur. Comm'n, Communication from the Commission Regarding the Guideline on the Data Fields Contained in the Clinical Trials Database Provided for in Article 11 of Directive 2001/20/EC to be Included in the Database on Medicinal Products Provided for in Article 57 of Regulation (EC) No 726/2004, 2008 OFFICIAL J. EUR. UNION C168/3, C 168/3(2008), available at http://ec.europa.eu/ health/files/eudralex/vol-10/2008-07/c-16820080703en00030004-en.pdf.
60. Eur. Comm'n, Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 Laying Down Community Procedures for the Authorisation and Supervision of Medicinal Products for Human and Veterinary Use and Establishing a European Medicines Agency, 2004 OFFICIAL J. EUR. UNION L 136/1, L 136/22-23(2004), available at http://ec.europa.eu/health/files/ eudralex/vol-1/reg-2004-726-cons/reg-2004-726-cons-en.pdf.
61. Ministerio de Salud, Resolution 102/2009, Criase el Registro de Ensayos Clinicos en Seres Humanos, LEGISALUD ARGENTINA, http://test.e-legis-ar.msal.gov. ar/leisref/public/showAct.php?id= 12916.
62. F. No. 12-01/09-DC-(Pt-32) Directorate General of Health Services, Office of Drugs Controller General (India) (New Drug Division), available at http://cdsco.nic.in/CTRegistration. doc.
63. See Roderick F. Viergever & Davina Ghersi, The Quality of Registration of Clinical Trials, 6 PLoS ONE at 1, 7 (2011)
64. (citing Japanese Ministry of Health, Labour and Welfare, Statement on Japan Primary Registries Network, MINISTRY OF HEALTH, LABOUR & WELFARE (2008), available at http://www.mhlw.go.jp/topics/2008/10/tp 1017-1.html).
65. Registration and Regulation, S. AFR. NAT'L CLINICAL TRIAL REG., http://www.sanctr.gov. za/Registrationandregulation/tabid/194/Default.aspx (last visited Dec. 26, 2011).
66. See, e.g., CANADIAN INST, OF HEALTH RESEARCH, NATURAL SCI. & ENGINEERING COUNCIL OF CANADA, SOC. SCI. & HUMANITIES RESEARCH COUNCIL OF CAN., Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans, PANEL ON RESEARCH ETHICS, 1, 156, 164 (2010).
67. Seth W. Glickman et al., Ethical and Scientific Implications of the Globalization of Clinical Research, 360 NEW ENG. J. MED. 816, 816 (2009).
68. Global Clinical Trial Business Report & Analysis 2008-2018, VISIONGAIN (Oct. 7, 2008), http://www.visiongain. eom/Report/315/Global- Clinical-Trial-Business-Report-Analysis-2008-2018.
69. Krleža-Jeric et al., Prospective Registration, supra note 11.
70. World Health Organization [WHO], WHO's Role and Responsibilities in Health Research: Bamako Global Ministerial Forum on Research for Health, at 4, WHO Doc. EB124/12 Add.2 (Jan. 6, 2009), available at http://new.paho.org/hq/ dmdocuments/2009/Bamako-Annex.pdf.
71. See Krleza-Jeric' et al., Prospective Registration, supra note 11, at 91.
72. Deborah A. Zarin et al., Trial Registration at ClinicalTrials.gov Between May and October 2005, 353 NEW ENG. J. MED. 2779, 2780 (2005).
73. FDA OFFICE OF SPECIAL HEALTH ISSUES, DEP'T OF HEALTH AND HUMAN SERVS., FDAMA SECTION 113: STATUS REPORT ON IMPLEMENTATION (2005), available at http://www.fda.gov/ForConsumers/ByAudience/ForPatientAdvocates/ ParticipatinginClinicalTrials/ucm 143810.htm.
74. Peter Gotzsche & Anders W. Jargensen, Opening Up Data at the European Drug Medicines Agency, 342 BRIT. MED. J. 1184 (2011).
75. One of the drugs has since been taken off the European market. See Tracy Hampton, European Drug Agency Under Fire, 306 JAMA 593, 593 (2011).
76. Federal Food, Drug, and Cosmetic Act of 2007, § 303 (f), 21 U. S. C. § 333 (3) (A) (B) (2011).
77. For an overview of the requirements and penalties, see Registration at ClinicalTrials.gov: As Required by Public Law 110-85, Title VIII, CLINICALTRIALS. GOV (Oct. 27, 2009), http://prsinfo.clinicaltrials.gov/s801- fact-sheet.pdf.
78. See CLINICALTRIALS. GOV, supra note 63.
79. See Eur. Comm., Enter, and Indus. Dir. Gen., List of Fields Contained in the 'Eudract' Clinical Trials Database to be Made Public, in Accordance with Article 57 (2) of Regulation (EC) No 726/2004 and its Implementing Guideline 2008/C168/02, EU Doc. ENTR/F/2/SF D (2009) 3687 (Feb. 4, 2009), available at http://ec.europa.eu/health/fiies/eudralex/vol-10/2009-02-04-guideline-en.pdf [hereinafter List of Fields]
80. See Pharmaceuticals: Today, the EU Register of Clinical Trials is Launched, EUROPA (Mar. 22, 2011), http://europa.eu/rapid/pressReleasesAction. do?reference=IP/l l/339&format=HTML& aged=0&language=EN. For details about what is included in the database
81. See List of Fields, supra note 65.
82. See Krleža-Jerić, Clinical Trial Registration, supra note 32;
83. see also Charlotte Haug, Peter C. Gatzsche & Torben V. Schoeder, Registries and Registration of Clinical Trials, 353 NEW ENG. J. MED. 2811, 2812 (2005).
84. Davina Ghersi et al., Reporting the Findings of Clinical Trials: A Discussion Paper, 86 BULL. WHO 492, 492 (2008).
85. Sally Hopwell et al., CONSORT for Report Randomized Controlled Trials in Journal and Conference Abstracts: Explanation and Elaboration, 5 PLOS MED. 0001, 0006-07 (2008).
86. See About the ICTRP, WORLD HEALTH ORG., http://www.who.int/ictrp/ aboufdetails/en/index 1.html
87. For an official statement, see EU Clinical Trials Register Recognized as "Primary Registry" of WHO's International Clinical Trials Registry Platform (European Meds. Agency, London, U. K.). Sept. 14, 2011. The team also reiterated, in a personal communication, the WHO senior management's continued commitment towards results reporting and indicated that it is actively seeking funding to strengthen the ICTRP. Persona! communications by e-mail with Karam Gassam, WHO IT officer, and Charlotte Bouesseau, February 9, 2012.
88. REPORT OF THE AUDITOR GENERAL OF CANADA TO THE HOUSE OF COMMONS, CHAPTER 4: REGULATING PHARMACEUTICAL DRUGS-HEALTH CANADA, at 12(2011), available at http://www.oag-bvg.gc.ca/internet/docs/parl oag 201111 04 e.pdf.
89. Matthew Herder, Unlocking Health Canada's Cache of Trade Secrets: Mandatory Disclosure of Clinical Trials Results, CAN. MED. ASS'N J. (Aug. 29, 2011), available at http://ecmaj.ca/content/early/2011/08/29/cmaj. 110721.full.pdf+html.
90. HEALTH CAN., HEALTH PRODUCTS & FOOD BRANCH, Blueprint for Renewal II (2007), available at http://www.hc-sc.gc.ca/ahc-asc/alt-formats/hpfb-dgpsa/pdf/ hpfb-dgpsa/blueprint-plan-lleng.pdf.
91. HEALTH Can., Notice: Registration and Disclosure of Clinical Trial Information (Nov. 2007), available at http://www.hc-sc.gc.ca/dhp-mps/alt- formats/hpfb-dgpsa/pdf/prodpharma/notice-ctregavis-ecenr-eng.pdf.
92. See Ann Silversides, Withdrawal of Clinical Trials Policy by Canadian Research Institute Is a "Lost Opportunity for Increased Transparency", 342 BRIT. MED. J. 1(2011), available at http://www.bmj.com/content/342ftmj. d2570.full.pdf;
93. Tom Blackwell, Reversal of Drug Trial Disclosure Policy Draws Fire, NAT'L POST (May 29, 2011), http://news.nationalpost.com/2011/05/29/reversal-on-drug- trial-disclosure-policy-draws-fire/.
94. Alain Beaudet, Message from the President-Policy on ethical conduct for research involving humans, CANADIAN INSTS. OF HEALTH RESEARCH (June 15, 2011), http://www.cihrirsc.gc.ca/e/43756.html.
95. See also Lisa Grimes, Clearer Road Ahead: An Industry Standard for Publicizing Clinical-Trial Results is a Ways Off But Pharma's Openness to More Transparent Procedures is Moving Things in the Right Direction, 25 PHARMACEUTICAL EXECUTIVE 104 (2005);
96. Ronald L. Krall, Trial Registration: Putting Principles into Practice, 330 BRIT. MED. J. 956 (2005).
97. Sheila Jasanoff, Transparency in Public Science: Purposes, Reasons, Limits, 69 LAW & CONTEMP. PROBS. 21, 34 (2006).
98. Gary Humphreys, Clinical Trials Initiative: Patients or Patents?, 84 BULL. WORLD HEALTH ORG. 509, 513 (2006).
99. WORLD HEALTH ORG., DEP'T OF RESEARCH POL'Y & COOPERATION, Summary: International Clinical Trials Registry Platform: Formal Consultation on Disclosure Timing (Apr. 26, 2006), available at http://www.who.int/ictrp/WHO- Formal-Consultation-Disclosure-Timing.pdf (personal notes of the meeting by Trudo Lemmens).
100. Trudo Lemmens & Ron A. Bouchard, Comments on the Legal, Regulatory and Ethical Aspects of the WHO Clinical Trial Registry Platform, WORLD HEALTH ORG. (Apr. 2006), available at http://www.who.int/ictrp/011-Lemmens-Bouchard- 5April06.pdf (submitted to the World Health Organization as part of its Formal Consultation on Disclosure Timing Policy, Geneva, Apr. 2006).
101. See WORLD HEALTH ORG., DEP'T OF RESEARCH POL'Y & COOPERATION, supra note 97. Davina Ghersi, who led the ICTRP secretariat until the reorganization of 2011, is also of the opinion
102. See, e.g., Letter from Alan Goldhammer, Associate Vice President, U. S. Regulatory Affairs, to ICTRP, RE: PhRMA's Second Round Comments on International Clinical Trials Registry Platform (ICTRP): Disclosure Timing, WORLD HEALTH ORG. (2006), available at http://www.who.int/ictrp/002-PhRMA-29March06.pdf;
103. Draft Issue Identification Paper: Registration and Disclosure of Clinical Trial Information, HEALTH CAN., at 16(2005), http://www.hc-sc.gc.ca/dhp-mps/ alt-formats/hpfbdgpsa/pdf/prodpharma/draftiipctrd-june-ddeebaucheedec-juin-2005- eng.pdf.
104. See, e.g., Letter from Alan Goldhammer, supra note 100.
105. Ida Sim, Trial Registration for Public Trust: Making the Case for Medical Devices, 23 J. GEN. ICTERNAL MED. 64, 67 (Supp. 2007).
106. See THE EUR. FED'N OF PHARM. INDUS. & ASS'NS., THE INT'L FED'N OF PHARM. MFRS. & ASS'NS., THE JAPANESE PHARM. MFRS. ASS'N, AND THE PHARM. RESEARCH & MFRS. OF AM., Joint Position on the Disclosure of Clinical Trial Information via Clinical Trial Registries (2005), available at http://www.roche.com/joint-position-clinicaltrials.pdf.
107. See COMM. ON CLINICAL TRIAL REGISTRIES, DEVELOPING A NATIONAL REGISTRY OF PHARMACOLOGIC AND BIOLOGIC CLINICAL TRIALS: WORKSHOP REPORT 30-32 (2006);
108. see also Karmela Krleža-Jerić, Clinical Trial Registration, supra note 32.
109. See Trudo Lemmens & Ron Bouchard, Mandatory Clinical Trial Registration: Rebuilding Trust in Medical Research, in 4 GLOBAL FORUM UPDATE ON RESEARCH FOR HEALTH, supra note 7, at 40.
110. See A Survey of Data Exclusivity Legislations, supra note 5.
111. See CARLOS MARIA CORREA, PROTECTION OF DATA SUBMITTED FOR THE REGISTRATION OF PHARMACEUTICALS: IMPLEMENTING THE STANDARDS OF THE TRIPS AGREEMENT 14 (2002) [hereinafter CORREA, PROTECTION OF Data].
112. See DANIEL GERVAIS, THE TRIPS AGREEMENT: DRAFTING HISTORY AND ANALYSIS 185 (3d ed. 1998).
113. See CORREA, PROTECTION OF DATA, supra note 113, at 8-9;
114. Carlos M. Correa, Unfair Competition Under the TRIPS Agreement: Protection of Data Submitted for the Registration of Pharmaceuticals, 3 CHI. J. INT'L L. 69, 70-71 (2002) [hereinafter Correa, Unfair Competition];
115. See CORREA, PROTECTION of DATA, supra note 113, at 25-46;
116. Correa, Unfair Competition, supra note 126, at 69.
117. For an overview of exclusivity provisions under FDA statutes and regulations, see Small Business Assistance: Frequently Asked Questions for New Drug Product Exclusivity, U. S. FOOD & DRUG ADMIN. (July 1, 2010), http://www.fda.gov/Drugs/DevelopmentApprovalProcess/SmallBusinessAssistance/ ucm069962.htm. Note that the FDA does not use the terms "data exclusivity" and "market exclusivity." For a good discussion of the terms and the confusion surrounding them in the context of recent controversy surrounding recent biosimilar legislation in the United States
118. see Market Exclusivity, Data Exclusivity and S. 3921, HOLMAN'S BIOTECH IP BLOG (Feb. 16, 2011, 10:03 AM), http://holmansbiotechipblog.blogspot.com/2011/ 02/market-exclusivity-data-exclusivity-and.html.
119. Drug Price Competition and Patent Term Restoration (Hatch-Waxman) Act of 1984, Pub. L. No. 98-417, 98 Stat. 1585 (1984).
120. For a discussion of the exclusivity provisions, see Kevin Outterson, Pharmaceutical Arbitrage: Balancing Access and Innovation in International Prescription Drug Markets, 5 YALE J. HEALTH POL'Y L. & ETHICS 193, 215-16 (2005).
121. see Saad Abughanm, THE PROTECTION OF PHARMACEUTICAL PATENTS AND DATA UNDER TRIPS AND US-JORDAN FTA: EXPLORING THE LIMITS OF OBLIGATIONS AND FLEXIBILITIES: A STUDY OF THE IMPACTS ON THE PHARMACEUTICAL SECTOR IN JORDAN, at 255-344 (2012) (unpublished S. J. D. dissertation, University of Toronto) (on file with author).
122. See COMM'N ON INTELLECTUAL PROP. RIGHTS, INNOVATION & PUB. HEALTH, WORLD HEALTH ORG., PUBLIC HEALTH, INNOVATION AND INTELLECTUAL PROPERTY RIGHTS 124(2006), available at http://www.who.int/entity/intellectualproperty/ documents/thereport/ENPublicHealth Report.pdf. The United Nations Conference on Trade and Development (UNCTAD) also suggested that article 39.3 does not prevent "authorities⋯ from using knowledge of such data, for instance, to assess subsequent applications by third parties for the registration of similar products"
123. UNCTAD Secretariat, The TRIPS Agreement and Developing Countries, U. N. Doc. UNCTAD/ITE/1, at 48 (1996).
124. CORREA, PROTECTION OF DATA, supra note 113, at 41-46;
125. CORREA, PROTECTION OF DATA, supra note 113, at 41 (giving, as examples, "competitor's misrepresentation, fraud threats, defamation, disparagement, enticement of employees, betrayal of confidential information commercial bribery, among others").
126. See FED. TRADE COMM'N, Authorized Generic Drugs: Short-Term Effects and Long-Term IMPACT 139-53(2001), available at http://www.ftc.gov/os/2011/08/201 lgenericdrugreport.pdf;
127. see also FED. TRADE COMM'N, PAY-FOR-DELAY: HOW DRUG COMPANY PAY-OFFS COST CONSUMERS BILLIONS 5(2010), http://www.ftc.gov/os/2010/01/100112payfordelayrpt. pdf.
128. Federal Insecticide, Fungicide, and Rodenticide Act, 7 U. S. C. § 136 (2006).
129. See CORREA, PROTECTION OF Data, supra note 113, at 8-9;
130. Correa, Unfair Competition, supra note 126, at 70-71;
131. See Joseph A. DiMasi, Ronald W. Hansen & Henry G. Grabowski, The Price of Innovation: New Estimates of Drug Development Costs, 22 J. HEALTH ECON. 151 (2003);
132. see also Z. John Lu & William S. Comanor, Strategic Pricing of New Pharmaceuticals, 80 REV. ECON. & STAT. 108, 108(1998), both providing higher cost estimates, which are invoked by industry.
133. Contra Donald W. Light & Joel Lexchin, Foreign Free Riders and the High Price of US Medicines, 331 BRIT. MED. J. 958(2005), available at http://www.bmj.com/content/331/7522/958.full;
134. Donald W. Light, Will Lower Drug Prices Jeopardize Drug Research? A Policy Fact Sheet, 4 AM. J. BIOETHICS WI, W3 (2005).
135. See Bayer Inc. v. Canada (Attorney General), [1999] 1 F. C. 553 (Can.), where the appellate court ruled that indirect reference to the data filed by an originator's New Drug Submission in an Abbreviated New Drug Submission (ANDS) by a generic company for the purpose of the establishment of pharmaceutical and biological equivalency implies neither an "evaluation" of nor a "reliance" on the originator's data. The court thus held that the ANDS procedure as it was conceived at that time was not in violation with the minimum data exclusivity period provided for in the North American Free Trade Agreement.
136. See also the discussion in CORREA, PROTECTION OF DATA, supra note 113, at 36-37.
137. see also SUSAN K. SELL, PRIVATE POWER, PUBLIC LAW: THE GLOBALIZATION OF INTELLECTUAL PROPERTY RIGHTS 139 (2003). Also see Sell's interesting overview of the global campaign to "correct" this neglect of the public health impact of TRIPS' patent provisions.
138. Note, Secretariat of the World Trade Org., "Necessity Tests" in the WTO, S/WPDR/W/27 (Dec. 2, 2003), available at http://ictsd.org/downloads/ 2008/04/nectest.pdf.
139. Correa, Unfair Competition, supra note 126, at 76
140. (citing MICHAEL J. TREBILCOCK & ROBERT HOWSE, THE REGULATION OF INTERNATIONAL TRADE 140 (2d ed. 1999)).
141. See Trudo Lemmens & Ron A. Bouchard, Regulation of Pharmaceuticals in Canada, in CANADIAN HEALTH LAW AND POLICY 318, 340 (Jocelyn Downie, Timothy Caulfield & Colleen Flood eds., 3d ed. 2007).
142. Joel Lexchin, TRANSPARENCY IN DRUG REGULATION: MIRAGE OR OASIS 7(2004), available at http://www.policyalternatives.ca/sites/default/files/uploads/ publications/National-Office-Pubs/transparency.pdf.
143. Christopher Doyle, Gimme Shelter: The "Necessary" Element of GATT Article XX in the Context of the China-Audiovisual Products Case, 29 B. U. INT'L L. J. 143, 163 (2011).
144. As Rebecca S. Eisenberg points out, "[t]he loss from secrecy is likely to be compounded as progress in information technology opens up greater possibilities for data mining across numerous studies." Rebecca S. Eisenberg, The Role of the FDA in Innovation Policy, 13 MICH. TELECOMM. & TECH. L. REV. 345, 383 (2007).
145. See Kevin Outterson, Death from the Public Domain?, 87 TEX. L. REV. 45, 53-54 (2009).
146. Ariel Katz, Pharmaceutical Lemons: Innovation and Regulation in the Drug Industry, 14 MICH. TELECOMM. & TECH. L. REV. 1 (2007).
147. See generally PHILIP J. HILTS, PROTECTING AMERICA'S HEALTH: THE FDA, BUSINESS, AND ONE HUNDRED YEARS OF REGULATION (2003) (discussing FDA history).
148. see the concerns expressed by the European Parliament about conflicts of interests and failures in appropriate action by the COMM. ON BUDGETARY CONTROL, EUR. PARLIAMENT, Report on Discharge in Respect of the Implementation of the Budget of the European Medicines Agency for the Financial Year 2009(2011), available at http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP// NONSGML+REPORT+ A7-2011-0153+0+DOC+PDF+V0//EN.
149. See also Inspection General Des Affaires Sociales, Enquete sur le Mediator® (RM20U-001P) Rapport definitive, DECISIONS SANTE (2011), http://www.decisionsante.com/fileadmin/uploads/MEDIATOR.pdf (describing the controversy in France surrounding Mediator).
150. Rebecca S. Eisenberg, Patents, Product Exclusivity, and Information Dissemination: How Law Directs Biopharmaceutical Research and Development, 72 FORDHAM L. REV. 477 (2003).
151. Health Omnibus Programs Extension of 1988, 42 U. S. C. § 201 (2006);
152. Food and Drug Administration Modernization Act of 1997, 21 U. S. C. § 301 (2006).
153. See Marie Hirtle, Trudo Lemmens & Dominique Sprumont, A Comparative Analysis of Research Ethics Review Mechanisms and the ICH Good Clinical Practice Guideline, 7 EUR. J. HEALTH L. 265 (2000).
154. See Justin E. Bekelman, Yan Li & Cary P. Gross, Scope and Impact of Financial Conflicts of Interest in Biomedical Research, 289 JAMA 454 (2003);
155. Joel Lexchin et al., Pharmaceutical Industry Sponsorship and Research Outcome and Quality: Systematic Review, 326 BRIT. MED. J. 1167 (2003).
156. For an overview of recent legal action and the unprecedented level of penalties imposed, see David Evans, Big Pharma's Crime Spree, BLOOMBERG MKTS. (Dec. 2009), http://www.bloomberg.com/apps/news?pid=nw&pname=mm-l 209-story2.html.
157. See, e.g., Adriane J. Fugh-Berman, The Haunting of Medical Journals: How Ghostwriting Sold 'HRT', 7 PLoS MED. 1, 1 (2010) (promoting HRT);
158. David Healy & Dinah Cattell, Interface between Authorship, Industry and Science in the Domain of Therapeutics, 183 BRIT. J. PSYCHIATRY 22 (2003) (promoting Zoloft);
159. Michael A. Steinman et al., Narrative Review: The Promotion of Gabapentin: An Analysis of Internal Company Documents, 145 ANNALS OF INTERNAL MED. 284 (2006);
160. S. Swaroop Vedula et al., Outcome Reporting in Industry-Sponsored Trials of Gabapentin for Off-label Use, 361 NEW ENG. J. MED. 1963 (2009) (promoting Neurontin).
161. See HOUSE OF COMMONS HEALTH COMM., THE INFLUENCE OF THE PHARMACEUTICAL INDUSTRY, FOURTH REPORT, 2004-5, H. C. 42-1 (U. K.), available at http://www.parliament.thestationery-office.co.uk/pa/cm200405/cmselect/cmhealth/ cmhealth.htm;
162. Enquête sur le Mediator®, supra note 160, § 731 (regarding the recent report by the French General Inspectorate of Social Affairs on regulatory failure and manipulation of data surrounding the obesity drug Mediator by the company. The report indicates that the company concealed evidence of lack of effectiveness and serious safety concerns related to its product, which according to preliminary estimates may have caused between 500 and 1000 deaths.).
163. See Simon Stern & Trudo Lemmens, Legal Remedies for Medical Ghostwriting: Imposing Fraud Liability on Guest Authors of Ghostwritten Articles, 8 PLoS MED. 1 (2011).
164. Erick H. Turner et al., Selective Publication of Antidepressant Trials and Its Influence on Apparent Efficacy, 358 NEW ENG. J. MED. 252 (2008).
165. See, e.g., Dean Fergusson et al., Association between Suicide Attempts and Selective Serotonin Reuptake Inhibitors: Systematic Review of Randomised Controlled Trials, 330 BRIT. MED. J. 396 (2005) (describing the lack of appropriate disclosure of adverse events in antidepressant trials).
166. See, e.g., Joel Lexchin, Those Who Have the Gold Make the Evidence: How the Pharmaceutical Industry Biases the Outcomes of Clinical Trials of Medications, SCI. & ENGINEERING ETHICSv (2011).
167. Emma C. Davies et al., Adverse Drug Reactions in Hospital In-Patients: A Prospective Analysis of 3695 Patient-Episodes, 4 PLoS ONE 1(2009), available at http://www.plosone.org/article/info%3Adoi%2F10.1371%2Fjournal.pone.0004439;
168. Jason Lazarou, Bruce H. Pomeranz & Paul N. Corey, Incidence of Adverse Drug Reactions in Hospitalized Patients: A Meta-Analysis of Prospective Studies, 279 JAMA 1200 (1998).
169. Daniel S. Budnitz et al., National Surveillance of Emergency Department Visits for Outpatient Adverse Drug Events, 296 JAMA 1858, 1860 (2006);
170. see also Karin Wester et al., Incidence of Fatal Adverse Drug Reactions: A Population Based Study, 65 BRIT. J. CLINICAL PHARMACOLOGY 573, 574 (2008) (noting that prior studies found the prevalence of hospital admissions from adverse effects of medication to range from 2.4% to 12.0%).
171. Lisa Girion, Scott Glover & Doug Smith, Drug Deaths Now Outnumber Traffic Fatalities in U. S., Data Show, L. A. TIMES, Sept. 17, 2011, http://articles.latimes.com/2011/sep/17/local/la-medrugs-epidemic-20110918.
172. See David J. Graham et al., Risk of Acute Myocardial Infarction and Sudden Cardiac Death in Patients Treated with Cyclo-Oxygenase 2 Selective and Non-Selective Non-Steroidal Anti-Inflammatory Drugs: Nested Case-Control Study, 365 LANCET 475, 480 (2005).
173. See Klim McPherson & Elina Hemminki, Synthesising Licensing Data to Assess Drug Safety, 328 BRIT. MED. J. 518, 518-19 (2004).
174. See Adam L. Hersh, Marcia L. Stefanick & Randall S. Stafford, National Use of Postmenopausal Hormone Therapy: Annual Trends and Response to Recent Evidence, 291 JAMA 47 (2004).
175. See, e.g., Prithwish De et al., Breast Cancer Incidence and Hormone Replacement Therapy in Canada, 102 J. Nat'L CANCER INST. 1489, 1493 (2010);
176. Peter M. Ravdin et al., The Decrease in Breast-Cancer Incidence in 2003 in the United States, 356 NEW ENG. J. MED. 1670 (2007).
177. See, e.g., Civil Settlement Agreement, United States v. Purdue Frederick Co., Inc., 495 F. Supp. 2d 569 (W. D. Va. 2007), available at http://www.vawd.uscourts.gov/PurdueFrederickCo/Exhibit-D.pdf.
178. see Curt D. Furberg et al., The FDA and Drug Safely: A Proposal for Sweeping Changes, 166 ARCHIVES INTERNAL MED. 1938 (2006);
179. Wayne A. Ray & C. Michael Stein, Reform of Drug Regulation-Beyond an Independent Drug-Safety Board, 354 NEW ENG. J. MED. 194 (2006);
180. See, e.g., Sanket S. Dhruva, Lisa A. Bero & Rita F. Redberg, Strength of Study Evidence Examined by the FDA in Premarket Approval of Cardiovascular Devices, 302 JAMA 2679 (2009);
181. Jonas Z. Hines et al., Left to Their Own Devices: Breakdowns in United States Medical Device Premarket Reviews, 7 PLoS MED. 1 (2010);
182. Diana M. Zukerman, Paul Brown & Steven E. Nissen, Medical Device Recalls and the FDA Approval Process, 171 ARCHIVES INTERNAL MED. 1006 (2011).
183. JEROME P. KASSIRER, On THE Take: How MEDICINE'S COMPLICITY WITH BIG BUSINESS CAN ENDANGER YOUR HEALTH (2004);
184. Description of The Cochrane Collaboration, THE COCHRANE COLLABORATION, http://www.cochrane.org/policy-manual/ll-description-cochrane-collaboration (last visited Jan. 29, 2012).
185. See Krleža-Jerić, Draft - The Ottawa Statement, supra note 32. Early recommendations for trial registration also suggested the need for more details on the clinical trials.
186. Steven Piantadosi & David P. Byar, Letter to the Editor: A Proposal for Registering Clinical Trials, 9 CONTROLLED CLINICAL TRIALS 82 (1988) (recommending the registration of full protocols).
187. See Audrey R. Chapman, The Human Rights Implications of Intellectual Property Protection, 5 J. INT'L ECON. L. 861, 867, 872 (2002).
188. See About Us, The COCHRANE COLLABORATION, http://www.cochrane.org/about- us (last visited Dec. 26, 2011)
189. The Constitution of South Africa explicitly recognizes the right to health. See Soobramoney v. Minister of Health (Kwazulu-Natal), supra note 3;
190. Minister of Health, supra note 3. In India, the constitutionally protected right to life has been interpreted as including a right to health.
191. See Paschim Banga Khet Mazdoor Samity & Ors v. State of West Bengal and Anor, A. I. R. 1996 S. C. 2426
192. -(1996) 4 S. C. C. 37 (India).
193. International Covenant on Economic, Social and Cultural Rights, G. A. Res. 2200A (XXI), U. N. OAOR, 21st Sess., Supp. No. 16, U. N. Doc. A/6316, at 49 (Dec. 16, 1966).
194. Special Rapporteur on the Right to Health, Addendum to the Report of the Special Rapporteur, U. N. Comm'n on Human Rights, Mission to the World Trade Organization, ¶ 15, U. N. Doc. E/CN.4/2004/49/Add.l (Mar. 1, 2004) [hereinafter Report of the Special Rapporteur].
195. Constitution of the World Health Organization, preamble, available at http://apps.who.int/gb/bd/PDF/bd47/EN/constitution-en.pdf.
196. O. A. Res. 2002/31, U. N. GAOR, 58th Sess., U. N. Doc. E/CN.4/RES/2002/31 (Apr. 24, 2002).
197. Paul Hunt, Towards Development: Human Rights and the WTO Agenda, Panel Presentation at World Trade Organization Ministerial Conference, Cancún, Mex. (Sept. 12, 2003), available at http://www.3dthree.org/pdf-3D/ Righttohealthandeconomicpolicy-English09-03.pdf.
198. Report of the Special Rapporteur, supra note 210, ¶¶ 18-20.
199. WORLD HEALTH ORG., ENGAGING FOR HEALTH: ELEVENTH GENERAL PROGRAMME OF WORK 2006-2015, at 2(2006), available at http://whqlibdoc.who.int/publications/ 2006/GPW-eng.pdf.
200. Report of the Special Rapporteur, supra note 210, 1¶¶ 18-19.
201. SANDRA COLIVER, THE RIGHT TO KNOW: HUMAN RIGHTS AND ACCESS TO REPRODUCTIVE HEALTH INFORMATION 45 (1995).
202. International Covenant on Civil and Political Rights, G. A. Res. 2200A (XXI), U. N. GAOR, 21st Sess., Supp. No. 16, 999, U. N. Doc. A/6316, at 52 (Dec. 16, 1966) [hereinafter ICCPR]. Freedom of expression and the right to information are also expressly recognized in essentially the same terms in the Universal Declaration of Human Rights (article 19), the U. N. Convention on the Rights of the Child (article 13), the American Convention (article 13), the European Convention for the Protection of Human Rights and Fundamental Freedoms (article 10), and the African (Banjul) Charter on Human and Peoples' Rights (article 9).
203. The United Nations referred to freedom of information as a freestanding right, though not formally through inclusion in one of the covenants: "Freedom of information is a fundamental human right and is the touchstone of all of the freedoms to which the United Nations is consecrated." Calling of an International Conference on Freedom of Information, G. A. Res. 59(1), U. N. GAOR, 1st Sess., U. N. Doc. A/RES/59 (I) (Dec. 14, 1946), available at http://daccess-dds-ny.un.org/doc/RESOLUTION/GEN/NR0/033/10/IMG/NR003310.pdf/ OpenElemen t;
204. Calling of an International Conference on Freedom of Information, G. A. Res. 59(1), supra note 219, at 46.
205. Council of Eur., European Convention for the Protection of Human Rights and Fundamental Freedoms, E. T. S.. 5 (Nov. 4, 1950), available at http://www.unhcr.org/refworld/docid/3ae6b3b04.html.
206. Open Door and Dublin Well Women v. Ireland, No. 14234/88, Eur. Ct. H. R. 68 (1992).
207. Informationsverein Lentia et al. v. Austria (1993), 276 Eur. Ct. H. R. (ser. A), at 93 (stating that the government is the "ultimate guarantor" of media pluralism, implying that it has a corresponding duty to promote media freedom);
208. see also Rebecca J. Cook & Mahmoud F. Fathalla, Duties to Implement Reproductive Rights, 67 NORDIC J. INT'L L. 1 (1998).
209. The Sunday Times v. The United Kingdom, 30 Eur. Ct. H. R. (ser. A), at 245 (1979).
210. The Sunday Times, 30 Eur. Ct. H. R. (ser. A), ¶ 66.
211. Ontario (Public Safety and Security) v. Criminal Lawyers' Association, [2010] 1 S. C. R. 8159 (Can.).
212. Ontario (Attorney General) v. Fraser, [2011] 2 S. C. R. 320 (Can.).
213. U. N. Educational, Scientific, and Cultural Organization, General Comment 14: The Right to the Highest Attainable Standard of Health, U. N. CESCR, 22nd Sess., Apr. 25 - May 12, 2000, U. N. Doc. E/C.12/2000/4 (Aug. 11, 2000) [hereinafter CESCR, GC 14]. While not binding instruments, general comments are generally viewed as having "considerable legal weight"
214. MATTHEW C. R. CRAVEN, THE INTERNATIONAL COVENANT ON ECONOMIC, SOCIAL, AND CULTURAL RIGHTS: A PERSPECTIVE ON ITS DEVELOPMENT 91 (1995).
215. RAJAT KHOSLA & PAUL HUNT, HUMAN RIGHTS GUIDELINES FOR PHARMACEUTICAL COMPANIES IN RELATION TO ACCESS TO MEDICINES: THE SEXUAL AND REPRODUCTIVE HEALTH CONTEXT 8(2009), available at http://www2.essex.ac.uk/human-rights-centre/rth/ docs/Final %20pharma%20for%20website.pdf.
216. The necessity of information to informed decision-making is echoed in Committee on the Elimination of Discrimination against Women, General Recommendation 24: Women and Health, U. N. CEDAW, 20th Sess., U. N. Doc. A/54/38, ¶ (20 (1999).
217. The Secretary-General, The Right of Everyone to the Enjoyment of the Highest Attainable Standard of Physical and Mental Health, U. N. GAOR, 61st Sess., U. N. Doc. A/61/338, ¶ (Sept. 13
218. see also Report of the Special Rapporteur, supra note 210, ¶ 38.
219. see BARBARA MlNTZES, DIRECT-TO-CONSUMER ADVERTISING OF PRESCRIPTION DRUGS IN CANADA: WHAT ARE THE PUBLIC HEALTH IMPLICATIONS? (Health Council of Can. ed., 2006)
220. and Colleen M. Flood, The Evidentiary Burden for Overturning Government's Choice of Regulatory Instrument: The Case of Direct-to-Consumer Advertising of Prescription Drugs, 60 U. TORONTO L. J. 397 (2010).
221. See Társaság a Szabadságjogokért v. Hungary, No 37374.05, Eur. Ct. H. R.. 618 (2009).
222. see 3D-> TRADE - HUMAN RIGHTS - EQUITABLE ECONOMY, TOWARDS HUMAN RLGHTS-CONSISTENT TRADE POLICIES: SAMPLES AND SUGGESTIONS FOR ENGAGING WITH HUMAN RIGHTS TREATY BODIES 2(2008), available at http://www.3dthree.org/pdf-3D/ HR&tradepolicies.pdf [hereinafter 3D].
223. Committee on Economic, Social, and Cultural Rights: Rep. on the 25th, 26th & 27th Sessions, Apr. 23-May 11, 2001, Aug. 13-31, 2001, Nov. 12-30, 2001, Human Rights and Intellectual Property, ¶ 4-5, U. N. ESCOR, 27th Sess., Annex XIII UN Doc. E/C. 12/2001/15 (2001) [hereinafter CESCR, Human Rights and Intellectual Property].
224. Laurence R. Heifer, Human Rights and Intellectual Property: Conflict or Coexistence, 5 MINN. INTELL. PROP. REV. 47, 48 n. 3 (2003)
225. (citing Robert Howse & Makau Mutua, Protecting Human Rights in a Global Economy: Challenges for the World Trade Organization (Int'l Ctr. for Human Rights & Democratic Dev., Policy Paper, 2000), available at http://www.ichrdd.ca/english/commdoc/publications/globalization/wtoRightsGlob. html));
226. see also Lisa Forman, An Elementary Consideration of Humanity? Linking Trade-Related Intellectual Property Rights to the Human Right to Health in International Law, 14 J. WORLD INTELL. PROP. 155 (2011.
227. Committee on the Rights of the Child, Consideration of Reports Submitted by States Parties Under Article 44 of the Convention: Concluding Observations - El Salvador, ¶ 48, U. N. Doc. CRC/C/15/Add. 232, 36th Sess., (June 30, 2004);
228. see Catherine D. De Angelis et al., Is This Clinical Trial Fully Registered? A Statement From the International Committee of Medical Journal Editors, 293 JAMA 2927, 2927 (2005);
229. Krleza-Jerid et al., Principles for International Registration, supra note 32 at 957;
230. Krleža-Jerić, Clinical Trial Registration, supra note 32, at 1093, 1095;
231. World Trade Organization, Ministerial Declaration of 14 November 2001, Declaration on the TRIPS Agreement and Public Health, WT/MIN (10)/DEC/2, 41 I. L. M. 755 (2002).
232. See Christopher Butler, Human Rights and the World Trade Organization: The Right to Essential Medicines and the TRIPS Agreement, 45 J. INT'L L. & POL'Y 5:1, 5:20-:26 (2007).
233. Additional Protocol to the American Convention on Human Rights in the Area of Economic, Social and Cultural Rights, Nov. 17, 1988, O. A. S. T. S. No. 69, available at http://www.cidh.org/Basic os/English/basic5. Prot. Sn%20Salv. htm [hereinafter San Salvador Protocol].
234. TARA MELISH, PROTECTING ECONOMIC, SOCIAL AND CULTURAL RIGHTS IN THE INTER-AMERICAN HUMAN RIGHTS SYSTEM: A MANUAL ON PRESENTING CLAIMS 46 (2002).
235. Jorge Odir Miranda Cortez et al. v. El Salvador, Case 12.249, Inter-Am. Comm'n. H. R. Report No. 29/01, OEA/Ser. L/V/II. Ill, doc. 20 rev. ¶ 1 (2000).
236. See, e.g., U. N. Office of the High Comm'r for Human Rights, Fact Sheet No. 16 (Rev. I), The Committee on Economic, Social and Cultural Rights, July 1991, http://www.ohchr.org/Documents/Publications/FactSheetl6rev. len.pdf [hereinafter OHCHR, Fact Sheet No. 16];
237. Inter-Am. Comm'n H. R., Annual Report of the Inter-American Commission on Human Rights, 1983-1984, § V (II) (2), OEA/Ser. L/V/11.63 doc. 10 (Sept. 24, 1984);
238. Comm. on Econ., Soc. and Cultural Rights: Report on the 5th Session, Nov. 26-Dec. 14, 1990, General Comment 3: The Nature of States Parties Obligations, ¶ 9, U. N. Doc. E/1991/23;
239. ESCOR, 5th Sess., Annex III (1990)
240. [hereinafter CESCR, GC 3].
241. CESCR, GC 3, supra note 269, ¶ 9;
242. OHCHR, Fact Sheet No. 16, supra note 266.
243. CESCR, Human Rights and Intellectual Property, supra note 249, ¶ 12.
244. CESCR, GC3, supra note 269, ¶ 10.