No CrossRef data available.
Published online by Cambridge University Press: 27 October 2017
This chapter explores how the EU is a largely overlooked exporter of normative power through its facilitation and use of clinical trials data produced abroad for the marketing of safe pharmaceuticals at home; a move that helps to foster the growing resort to pharmaceuticals as a fix for public health problems. This is made possible by the EU’s (de)selection of international ethical frameworks in preference to the international technical standards it co-authors with other global regulators. Clinical trials abroad underscore how ethics are contingent and revisable in light of market needs, producing weak protections for the vulnerable subjects of EU law. I argue that these components and effects of the regime are ultimately about that which undergirds, shapes and directs regulatory design. That is, I point to the use, infiltration, perpetuation and extension of market-oriented ideas, values and rationalities into formally non-market domains like biomedical knowledge production and public health. I explain how these are central to efforts at producing and legitimating the EU, its related imagined socio-political order based on a more innovative, profitable and competitive pharmaceutical sector in order to foster economic growth, jobs and prosperity, and with them the project of European integration. ‘Bioethics as risk’ is highlighted as a way to reshape and redirect the regulatory regime in ways that are more consistent with the spirit and letter of the ethical standards (and through them the human rights) the EU claims to uphold.
3 All noted in the (business) media, for example: A Jack, ‘A New Lease of Life? The Ethics of Offshoring Clinical Trials’, Financial Times, 28 January 2008; N Singer, ‘Outsourcing of Drug Trials Is Faulted’, New York Times, 18 February 2009.
4 Abraham, J, ‘Evolving Sociological Analyses of “Pharmaceuticalisation”: A Response to Williams, Martin and Gabe’ (2011) 33 Sociology of Health & Illness 726 CrossRefGoogle Scholar; Biehl, J, ‘Pharmaceuticalisation: AIDS Treatment and Global Health Politics’ (2007) 80 Anthropological Quarterly 1083 CrossRefGoogle Scholar; Williams, SJ, Gabe, J and Davis, P, ‘The Sociology of Pharmaceuticals: Progress and Prospects’ (2008) 30 Sociology of Health & Illness 813 CrossRefGoogle ScholarPubMed; Williams, SJ, Martin, P and Gabe, J, ‘Evolving Sociological Analyses of “Pharmaceuticalisation”: A Reply to Abraham’ (2011) 33 Sociology of Health & Illness 729 CrossRefGoogle Scholar; Williams, SJ, Martin, P and Gabe, J, ‘The Pharmaceuticalisation of Society? A Framework for Analysis’ (2011) 33 Sociology of Health & Illness 710 CrossRefGoogle Scholar.
5 Pharmaceuticalisation is arguably especially apparent in contexts of rare but potentially high impact medical emergencies like global pandemics in which vaccines and medicines are stockpiled in preparedness planning for surge capacity and distribution by triage. There is a notable trend in non-emergency contexts too: S Boseley and others, ‘Antidepressant use on the rise in rich countries, OECD finds’, The Guardian, 20 November 2013.
7 With some notable exceptions, such as Jackson, E, Law and the Regulation of Medicines (Oxford, Hart Publishing, 2012)Google Scholar.
8 Further analysis could bring out how the underpinning norms that shape EU law go above or beyond those which characterise national frameworks, whether those of the EU’s Member States or of the US. This chapter is concerned with highlighting the norms, orientation and importance of the EU’s regime—rather than a more comparative study.
9 Black’s definition of regulation is ‘the intentional use of authority to affect behaviour of a different party according to set standards, involving instruments of information-gathering and behaviour modification’ ( Black, J, ‘Critical Reflections on Regulation’ (2002) 27 Australian Journal of Legal Philosophy 1)Google Scholar.
11 CfCloatre, E, Pills for the Poorest. An Exploration of TRIPS and Access to Medication in Sub-Saharan Africa (Basingstoke, Palgrave Macmillan, 2013)Google Scholar.
12 See: Abraham, J and Lawton-Smith, H (eds), Regulation of the Pharmaceutical Industry (Basingstoke, Palgrave, 2003)CrossRefGoogle ScholarPubMed; Aronson, J, Genetic Witness: Science, Law, and Controversy in the Making of DNA Profiling (Piscataway, Rutgers University Press, 2007)Google Scholar; Cloatre, E and Pickersgill, MD (eds), Knowledge, Technology and Law (London, Routledge, 2014)Google Scholar; Daemmrich, A, Pharmacopolitics: Drug Regulation in the United States and Germany (Chapel Hill NC, University of North Carolina Press, 2006)Google Scholar; Hindmarsh, R and Prainsack, B (eds), Genetic Subjects: Global Governance of Forensic DNA Profiling and Databasing (Cambridge, Cambridge University Press, 2010)CrossRefGoogle Scholar; Jasanoff, S (ed), Reframing Rights: Bioconstitutionalism in the Genetic Age (Cambridge MA, MIT Press, 2011)CrossRefGoogle Scholar.
13 The establishment of the internal market is required by Art 3(3) as amended TEU.
14 Arts 28–36 TFEU. Pharmaceuticals are goods for these purposes ie, ‘products which can be valued in money and which are capable, as such, of forming the subject of commercial transactions’ (Case 7/68 Commission v Italy (Art Treasures case)  ECR 423).
15 Foucault, M, Security, Territory, Population: Lectures at the Collège de France, 1977–1978 (Basingstoke, Palgrave Macmillan, 2007) 48–49 Google Scholar.
16 Ibid, 47.
18 That is, bovine spongiform encephalopathy.
19 For discussion, see: Everson, M and Vos, E, ‘The Scientification of Politics and the Politicisation of Science’ in Everson, M and Vos, E (eds), Uncertain Risks Regulated (Abingdon, Routledge-Cavendish, 2009)Google Scholar.
22 Ong, A, Neoliberalism as Exception: Mutations in Citizenship and Sovereignty (Durham NC, Duke University Press, 2006) 3 CrossRefGoogle Scholar. See also: Dean, M, Governmentality: Power and Rule in Modern Society (London, Sage, 1999)Google Scholar; Flynn, R, ‘Health and Risk’ in Mythen, G and Walklate, S (eds), Beyond the Risk Society (Maidenhead, Open University Press, 2006)Google Scholar.
26 Beck, U, Risk Society: Towards a New Modernity (London, Sage, 1986)Google Scholar; Beck, U, World at Risk (Cambridge, Polity Press, 2009)Google Scholar; Giddens, A, ‘Risk Society: The Context of British Politics’ in Franklin, J (ed), The Politics of Risk Society (Cambridge, Polity Press, 1998)Google Scholar.
27 Such as: ‘moral pioneers’ in Rapp, R, Testing Women, Testing the Fetus: The Social Impact of Amniocentesis in America (London, Routledge, 2000)Google Scholar; ‘biological citizens’ in Rose, N and Novas, C, ‘Biological Citizenship’ in Ong, A and Collier, S (eds), Global Assemblages: Technology, Politics, and Ethics as Anthropological Problems (Oxford, Blackwell, 2005)Google Scholar, cfBiehl, J, Will to Live: AIDS Therapies and the Politics of Survival (Princeton NJ, Princeton University Press, 2007)Google Scholar; ‘therapeutic citizens’ in Nguyen, V-K, ‘Antiretroviral Globalism, Biopolitics, and Therapeutic Citizenship’ in Ong, A and Collier, J (eds), Global Assemblages (Oxford, Blackwell, 2005)Google Scholar.
28 Arts 18–25 TFEU.
29 It also includes eg, those whose treatments are not the focus of trials or who do not have access to comprehensive data on trial results (discussed below) and therefore cannot make informed decisions on treatment options.
30 Originating in Foucault’s work, this term has been widely discussed. See further: Lemke, T, Biopolitics (London, New York University Press, 2011)Google Scholar.
31 This tendency is apparent in relation to, say, new diagnostic technologies, which make possible certain discourses on risk for those trying to determine their individual risk of cancer ( Robertson, A, ‘Biotechnology, Political Rationality and Discourses on Health Risk’ (2001) 5 Health 293)CrossRefGoogle Scholar. More generally see: Gray, GC, ‘The Responsibilisation Strategy of Health and Safety: Neo-liberalism and the Reconfiguration of Individual Responsibility for Risk’ (2009) 49 British Journal of Criminology 326 CrossRefGoogle Scholar.
33 Petryna, A and Kleinman, A, ‘The Pharmaceutical Nexus’ in Petryna, A and others (eds), Global Pharmaceuticals: Ethics, Markets, Practices (Durham NC, Duke University Press, 2006)CrossRefGoogle Scholar; Whyte, SR and others, Social Lives of Medicines (Cambridge, Cambridge University Press, 2003)Google Scholar, especially ‘Drug Vendors and Their Market: The Commodification of Health’.
34 See further: Scott, C, ‘Accountability in the Regulatory State’ (2000) 27 Journal of Law and Society 38 CrossRefGoogle Scholar; Scharpf, F, Governing in Europe. Effective and Democratic? (Oxford, Oxford University Press, 1999)CrossRefGoogle Scholar; Arnull, A and Wincott, D, Accountability and Legitimacy in the European Union (Oxford, Oxford University Press, 2002)Google Scholar.
35 Art 5(4) TEU.
36 Art 5(3) TEU.
37 European Commission, White Paper, Together for Health: A Strategic Approach for the EU 2008–2013, COM(2007) 630 final; European Commission, Commission Staff Working Document Accompanying White Paper, Together for Health: A Strategic Approach for the EU 2008–2013, SEC(2007) 1376. For an overview of initiatives, see European Commission, Commission Staff Working Document, Report on European Governance (2003–2004), SEC(2004) 1153.
38 European Commission, Together for Health, ibid, 2.
39 European Commission, Together for Health, n 37 above, 2. On the Lisbon Strategy, see further: Armstrong, K, ‘Governance and Constitutionalism After Lisbon’ in JCMS Symposium: EU Governance After Lisbon (2008) 46 Journal of Common Market Studies 413 Google Scholar. The Lisbon Strategy was subsequently refocused on growth and jobs: Kok, W, Facing the Challenge: The Lisbon Strategy for Growth and Employment. Report from the High Level Group Chaired by Wim Kok (Brussels, European Commission, 2004)Google Scholar.
42 See, generally, ‘Europe 2020’: http://ec.europa.eu/europe2020/index_en.htm. Also see: European Commission, Smart Regulation in the European Union, COM(2010) 543 final; European Commission, Europe 2020 Flagship Initiative Innovation Union, COM(2010) 546 final.
45 ‘Europe 2020’, n 42 above.
46 European Commission, A Stronger European-Based Pharmaceutical Industry for the Benefit of the Patient—A Call for Action, COM(2003) 383 final; European Commission, Putting Knowledge into Practice: A Broad-based Innovation Strategy for the EU, COM(2006) 502 final.
47 And approval figures are important for communicating success and performance: ‘EMA Recommends 81 Medicines for Marketing Authorisation in 2013’, www.ema. europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2014/01/news_detail_002006.jsp&mid=WC0b01ac058004d5c1.
48 Comparisons between the EU and FDA include ‘EMA Bests FDA in 2013 New Drug Approval Numbers’: www.raps.org/focus-online/news/news-article-view/article/4519/emabests-fda-in-2013-new-drug-approval-numbers.aspx; LJ Howie and others, ‘A Comparison of FDA and EMA Drug Approval: Implications for Drug Development and Cost of Care’ (2013) Oncology www.cancernetwork.com/oncology-journal/comparison-fda-and-ema-drugapproval-implications-drug-development-and-cost-care#sthash.SO6MTTLW.dpuf.
49 For an overview see ‘Authorisation procedures for medicinal products’: http://ec.europa.eu/health/authorisation-procedures_en.htm.
50 Regulation 726/2004/EC laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing the European Medicines Agency.
51 Directive 2001/83/EC on the Community code relating to medicinal products for human use.
52 Directive 2001/20/EC on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use. This requires the Commission to establish principles relating to good clinical practice and detailed rules in line with those principle.
53 Directive 2005/28/EC laying down principles and detailed guidelines for good clinical practice as regards investigational medicinal products for human use, as well as the requirements for authorisation of the manufacturing or importation of such products.
54 For an overview of the EU approach see: http://ec.europa.eu/health/human-use/clinical-trials/index_en.htm.
55 Directive 2001/83/EC, Annex I, Part 4.
56 Jackson, Law and the Regulation of Medicines, n 7 above, 29.
57 More generally, see: Cartwright, N, ‘What is this Thing Called “Efficacy”?’ in Mantzavinos, C, Philosophy of the Social Sciences: Philosophical Theory and Scientific Practice (Cambridge, Cambridge University Press, 2009)Google Scholar.
58 EMA, Reflection Paper on the Need for Active Control in Therapeutic Areas Where Use of Placebo is Deemed Ethical and One or More Established Medicines are Available, EMA/759784/2010, 3–4.
59 Ibid, 4.
60 Directive 2001/83, Art 8(3)(i) mentions the results of clinical trials, submitted in accordance with Annex I, as particulars and documents that ‘shall’ accompany an application for market authorisation.
61 Directive 2001/83, Annex 1, Part 4, B, 1.2. Also see: Directive 2001/20, Art 2(j).
62 Directive 2001/83, Annex 1, Part 4, B, 1.1. Also see: Directive 2001/20, Art 8.
63 EMA, EMEA Strategy Paper: Acceptance of Clinical Trials Conducted in Third Countries, for Evaluation in Marketing Authorisation Applications, EMEA/228067/2008.
64 Ibid, 1.
65 Directive 2001/83/EC, Recital 2.
66 Directive 2001/83/EC, Recital 3.
67 For instance, on claims about justice and access to the benefits of research see: Kahn, JP and others, Beyond Consent: Seeking Justice in Research (Oxford, Oxford University Press, 1998)Google Scholar.
68 Institutional review boards in the US. See further: Bosk, CL, ‘Professional Ethicist Available: Logical, Secular, Friendly. Bioethics and Beyond’ (1999) 128 Daedalus 47 Google Scholar; Bosk, CL and de Vries, RG, ‘Bureaucracies of Mass Deception: Institutional Review Boards and the Ethics of Ethnographic Research’ (2004) 595 Annals of the American Academy of Political and Social Science 249 CrossRefGoogle Scholar; Guillemin, J, ‘Bioethics and the Coming of the Corporation to Medicine’ in de Vries, R and Subedi, J (eds), Bioethics and Society (Upper Saddle River NJ, Prentice Hall, 1998)Google Scholar.
69 Reflecting: Universal Declaration of Human Rights, itself highly influenced by the Nuremberg Code; International Covenant on Civil and Political Rights; International Covenant on Economic, Social and Cultural Rights; Convention on the Elimination of All Forms of Discrimination against Women; Convention on the Rights of the Child.
70 Annas, GJ and Grodin, MA (eds), The Nazi Doctors and the Nuremburg Code: Human Rights in Human Experimentation (Oxford, Oxford University Press, 1992)Google Scholar.
71 Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects, available at: www.wma.net/en/30publications/10policies/b3/17c.pdf.
72 Marks, HM, The Progress of Experiment: Science and Therapeutic Reform in the United States, 1900-1990 (Cambridge, Cambridge University Press, 1997)Google Scholar.
73 Declaration of Helsinki, n 71 above, para 7.
74 Craig, P and de Búrca, G, EU Law: Text, Cases and Materials, 5th edn (Oxford, Oxford University Press, 2013), ch 11Google Scholar.
75 Directive 2001/20/EC, Art 3.
76 Directive 2001/20/EC, Recitals 3, 4, 16, Arts 2–5.
77 Ibid, Recital 2.
78 Directive 2001/20/EC, Recital 6.
79 Ibid, Recitals 3 and 4. For instance, Recital 3 reads that they should be included in clinical trials only ‘when there are grounds for expecting that the administering of the medicinal product would be of direct benefit to the patient, thereby outweighing the risks’.
80 Ibid, Recital 9 and Art 11(3).
81 Directive 95/46/EC on the protection of individuals with regard to the processing of personal data and on the free movement of such data. This includes data in health care settings, including research and development of pharmaceuticals and medical technologies more broadly. See also European Commission, Proposal for a Regulation of the European Parliament and of the Council on the protection of individuals with regard to the processing of personal data and on the free movement of such data (General Data Protection Regulation), COM(2012) 11 final.
82 Directive 2001/20/EC, Recital 2.
83 Directive 2001/20/EC, Arts 1(3) and 8.
84 Directive 2001/20/EC, Art 1(2).
85 EMA, E6: Guideline for Good Clinical Practice, CPMP/ICH/135/95. Also see ‘Inspections procedure’: www.emea.europa.eu/ema/index.jsp?curl=pages/regulation/document_listing/document_listing_000140.jsp&mid=WC0b01ac05800296c6.
87 WHO, Effective Medicines Regulation: Ensuring Safety, Efficacy and Quality, WHO Policy Perspectives on Medicines (Geneva, WHO, 2003)Google Scholar.
88 Directive 2001/20/EC, Art 1(4).
89 Ibid, Art 2(1).
90 Ibid, Recital 3.
91 For instance, the standard for professional liability in English tort law is notoriously high (Bolam v Friern Hospital Management Committee  1 WLR 582), although it has gradually become less so (Bolitho v City and Hackney Health Authority  4 All ER 771). Art 3(2)(f) Directive 2001/20/EC requires ‘provision has been made for insurance or indemnity to cover the liability of the investigator and sponsor’ before any clinical trial is undertaken.
92 Petryna, When Experiments Travel, n 1 above, 77.
94 Jonas, H, ‘Philosophical Reflections on Human Experimentation’ (1969) 98 Daedalus 219 Google Scholar.
99 Jacob, M-A, ‘Form-Made Persons: Consent Forms as Consent’s Blind Spot’ (2007) 30 Political and Legal Anthropology Review 249 CrossRefGoogle Scholar. See further: Jacob, M-A and Riles, A, ‘The New Bureaucracies of Virtue: Introduction’ (2007) 30 Political and Legal Anthropology Review 181 CrossRefGoogle Scholar.
100 For discussion see: Jackson, Law and the Regulation of Medicines, n 7 above, 43–47.
101 Fisher, JA, ‘Co-ordinating “Ethical” Clinical Trials: The Role of Research Coordinators in the Contract Research Industry’ (2006) 27 Sociology of Health & Illness 678 CrossRefGoogle Scholar. On compliant research subjects see: Fisher, JA, Medical Research for Hire: The Political Economy of Pharmaceutical Clinical Trials (New Brunswick NJ, Rutgers University Press, 2009)Google Scholar.
103 Nguyen, V-K, ‘Antiretroviral Globalism, Biopolitics, and Therapeutic Citizenship’ in Ong, A and SCollier, J (eds), Global Assemblages (Oxford, Blackwell, 2005) 139 Google Scholar.
104 Anderson, W, The Cultivation of Whiteness: Science, Health, and Racial Destiny in Australia (New York, Basic Books, 2003)Google Scholar; Arnold, D, Colonising the Body: State Medicine and Epidemic Disease in Nineteenth-Century India (Berkeley CA, University of California Press, 1993)Google Scholar; Biehl, J, Vita: Life in a Zone of Social Abandonment (Berkeley CA, University of California Press, 2003)Google Scholar; Vaughan, M, Curing Their Ills: Colonial Power and African Illness (Stanford CA, Stanford University Press, 1992)Google Scholar.
105 Jonas, ‘Philosophical Reflections’, n 94 above.
106 Petryna, When Experiments Travel, n 1 above, 25.
108 Burroughs, VJ, ‘Racial and Ethnic Inclusiveness in Clinical Trials in Ethics and the Pharmaceutical Industry’ in Santoro, MA and Gorrie, TM (eds), Ethics and the Pharmaceutical Industry (Cambridge, Cambridge University Press, 2005)Google Scholar.
109 Petryna, n 1 above.
112 Petryna, , ‘Clinical Trials Offshored: On Private Sector Science and Public Health’, n 1 above, 24 Google Scholar.
114 For extensive discussion see: Jackson, Law and the Regulation of Medicines, n 7 above, 50–56.
115 Helsinki Declaration, n 71 above, para 19.
116 The revision of the CTD by the new Clinical Trials Regulation (European Commission, Proposal for a Regulation of the European Parliament and of the Council on Clinical Trials on Medicinal Products for Human Use, and Repealing Directive 2001/20/EC, COM(2012) 369 final and to come into force in 2016) is designed to increase transparency, but it will not change the position in relation to trials carried out outside the EU. See further: European Commission, Q&A: New Rules for Clinical Trials Conducted in the EU, MEMO/14/254. The EMA currently only provides access to summaries of clinical trials data once the decision making process on market authorisation has been completed, see further: ‘Release of data from clinical trials’, at: www.ema.europa.eu/ema/index.jsp?curl=pages/special_topics/general/general_content_000555.jsp.
117 Directive 2001/83/EC, Annex 1, Part 4, F, 1.
119 Directive 2001/20; Directive 2005/28.
120 EGE, Opinion on the Ethical Aspects of Clinical Research in Developing Countries (Opinion No 17) para 2.10.
121 CIOMS Guidelines 8 and 11.
122 That is, ‘given their socioeconomic circumstances, laws and regulations, and executive and administrative arrangements’. The Council’s name gives the guidelines their abbreviated name of CIOMS. The guidelines have been updated twice, the last time being in 2002. See further: www.cioms.ch/publications/guidelines/guidelines_nov_2002_blurb.htm.
123 EMA, Reflection Paper on Ethical and GCP Aspects of Clinical Trials of Medicinal Products for Human Use Conducted Outside of the EU/EEA and Submitted in Marketing Authorisation Applications to the EU Regulatory Authorities, EMA/121340/2011, 26.
125 B Djulbegovic and others, ‘The Uncertainty Principle and Industry-Sponsored Research Research’ (2000) 356 The Lancet 635.
126 EMA, n 124 above, 27.
127 RK Lie and others, ‘The Standard of Care Debate: The Declaration of Helsinki Versus the International Consensus Option’ (2004) Journal of Medical Ethics 190.
128 EGE, n 121 above, para 2.10.
129 Landes, M, ‘Can Context Justify an Ethical Double Standard for Clinical Research in Developing Countries?’ (2005) 1 Globalisation and Health 11 CrossRefGoogle ScholarPubMed; Schüklenk, U, ‘The Standard of Care Debate: Against the Myth of an “International Consensus Opinion”’ (2004) 30 Journal of Medical Ethics 194 CrossRefGoogle ScholarPubMed. One study found that ‘only 16% of the trials conducted in resource-poor settings provided therapy that could be considered consistent with the best current standard of care, even when the Declaration of Helsinki required that standard’. See: Kent, D and others, ‘Clinical Trials in Sub-Saharan Africa and Established Standards of Care: A Systematic Review of HIV, Tuberculosis, and Malaria Trials’ (2004) 292 Journal of the American Medical Association 237, 241CrossRefGoogle ScholarPubMed.
130 European Medicines Evaluation Agency, which lost mention of ‘evaluation’ in 2009.
131 EMEA, EMEA/CPMP Position Statement on the Use of Placebo in Clinical Trials with Regard to the Revised Declaration of Helsinki, EMEA/17424/01, 1.
132 Ibid, p 1.
133 See further: ‘Good clinical practice compliance’: www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000072.jsp.
134 US Food and Drug Administration, ‘Human Subject Protection; Foreign Clinical Studies Not Conducted Under an Investigational New Drug Application—Notice of Final Rule’ see: www.regulations.gov/#!documentDetail;D=FDA-2004-N-0061-0002;oldLink=false.
135 EMEA, n 132 above, 1.
136 Ibid, 1–2.
137 Ibid, 2.
138 In 2008 the Helsinki Declaration was revised such that para 33 now clarifies and provides increased scope for placebo use and, for present purposes, EU law is arguably in-line with it.
141 EGE, n 120 above.
142 European Commission, Towards a European Research Area, COM(2000) 6 final; European Commission, Putting Knowledge into Practice: A Broad-based Innovation Strategy for the EU, COM(2006) 502 final. For discussion, see: Bache, G, Flear, ML and Hervey, TK, ‘The Defining Features of the European Union’s Approach to Regulating New Health Technologies’ in Flear, ML and others (eds), European Law and New Health Technologies (Oxford, Oxford University Press, 2013)Google Scholar.
143 Emanuel, EJ, ‘Addressing Exploitation: Reasonable Availability versus Fair Benefits’ in Hawkins, JS and Emanuel, EJ (eds), Exploitation and Developing Countries: The Ethics of Clinical Research (Princeton NJ, Princeton University Press, 2008)Google Scholar.
144 Such as the World Health Organisation’s essential drugs list, the Global Fund, and the Gate Foundation’s support of the latter and other initiatives. For discussion see: Greene, JA, ‘Making Medicines Essential: The Emergent Centrality of Pharmaceuticals in Global Health’ (2011) 6 BioSocieties 10 CrossRefGoogle Scholar; Yamada, T, ‘Global Health and the Bill & Melinda Gates Foundation’ (2009) 373 The Lancet 2195 CrossRefGoogle Scholar.
145 EGE, n 120 above, para 2.10.
146 For discussion see: Benatar, SR, ‘Distributive Justice and Clinical Trials in the Third World’ (2001) 22 Theoretical Medicine and Bioethics 169 CrossRefGoogle ScholarPubMed; Benatar, SR and Singer, PA, ‘A New Look at International Research Ethics’ (2000) 321 British Medical Journal 824 CrossRefGoogle Scholar; Farmer, P, ‘Can Transnational Research Be Ethical in the Developing World?’ (2002) 360 Lancet 1301 CrossRefGoogle ScholarPubMed; Rothman, DJ, ‘The Shame of Medical Research’ (2000) 47 New York Review of Books 60 Google Scholar; Schuklenk, U and Ashcroft, R, ‘International Research Ethics’ (2000) 14 Bioethics 158 CrossRefGoogle ScholarPubMed.
147 Marrakesh Agreement Establishing the World Trade Organization, opened for signature 15 April 1994, 1867 UNTS 3, annex 1C (Agreement on Trade-Related Aspects of Intellectual Property Rights) (entered into force 1 January 1995) (TRIPS). This agreement is enforceable via the WTO’s Understanding on Dispute Settlement. Least developed countries do not have to implement TRIPS until 2016. The EU and its MSs are all members as required by their membership of the World Trade Organisation. TRIPS came into force on 1 January 1995 and in signing up to it (WTO) MSs agree to recognise one single global patent that lasts 20 years and to forbid generic equivalents of the patented drug from entering the marketplace during that period. Under TRIPS it is for MSs to determine what deserves to be patented, and as such countries in the industrialised global North, ie, where the biggest producers of pharmaceuticals have their homes, are effectively able to export their patent protections.
148 An alternative route is through so-called ‘parallel importation’, which occurs when a state imports a patented medicine from another state where it is available at a lower price, but without patent owner approval.
149 For instance, Apotex spent three years struggling to obtain a licence for the use of three drugs in a combined treatment for HIV/AIDS, but eventually it was made available in Rwanda. See: Davies, SE, Global Politics of Health (Cambridge, Polity Press, 2010) 169 Google Scholar. Also see: Rimmer, M, ‘Race against Time: The Export of Essential Medicines to Rwanda’ (2008) 1 Public Health Ethics 89 CrossRefGoogle Scholar.
150 Cloatre, n 11 above.
151 Declaration on the TRIPS Agreement and Public Health (adopted 14 November 2001) WTO Doc WT/MIN(01)/DEC/2 (Doha Declaration).
152 Article 31(b) See: Cassier, M and Correa, M, ‘Patents Innovation and Public Health: Brazilian Public-Sector Laboratories’ Experience in Copying AIDS Drugs’ in Economics of AIDS and Access to HIV/AIDS Care in Developing Countries: Issues and Challenges (Paris, ANRS, 2003)Google Scholar.
153 An interpretation supported by the World Trade Organisation (WTO), ‘Declaration on the TRIPs Agreement and Public Health’, 9–14 November 2001), Ministerial Conference Fourth Session (WT/MIN(01)/DEC/W/2) (‘Doha Declaration’), para 5(c).
154 Dreyfuss, RC, ‘TRIPS and Essential Medicines: Must One Size Fit All? Making the WTO Responsive to the Global Health Crisis’ in Pogge, T and others (eds), Incentives for Global Public Health: Patent Law and Access to Essential Medicines (Cambridge, Cambridge University Press, 2010), 55 Google Scholar.
157 Implementation of Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health: Decision of 30 August 2003, WTO Doc WT/L/540; Amendment of the TRIPS Agreement: Decision of 6 December 2005, WTO Doc WT/L/641.
158 Mitchell, A and Voon, T, ‘Patents and Public Health in the WTO, FTAs and Beyond: Tension and Conflict in International Law’ (2009) 43 Journal of World Trade 571 Google Scholar.
159 Such as the EU-India bilateral agreement, see further: Oxfam, , Trading Away Access to Medicines: How the European Union’s Trade Agenda has taken a Wrong Turn (Oxfam, 2009)Google Scholar.
160 Oxfam India, Oxfam Urges India to Remain ‘Pharmacy of the Developing World’ (Oxfam, 2010)Google Scholar. Also see: Ecks, S, ‘Global Pharmaceutical Markets and Corporate Citizenship: The Case of Novartis’ Anti-cancer Drug Glivec’ (2008) 3 BioSocieties 165 CrossRefGoogle Scholar; Pollock, A, ‘Transforming the Critique of Big Pharma’ (2011) 6 BioSocieties 106 CrossRefGoogle Scholar; Ruger, JP and Ng, NY, ‘Emerging and Transitioning Countries’ Role in Global Health’ (2010) 3 Saint Louis University Journal of Health Law & Policy 253 Google ScholarPubMed.
161 Cfde Búrca, G and Scott, J, EU and the WTO: Legal and Constitutional Issues (Oxford, Hart Publishing, 2001)Google Scholar.
No CrossRef data available.