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Clinical Trials Abroad: The Marketable Ethics, Weak Protections and Vulnerable Subjects of EU Law

Published online by Cambridge University Press:  27 October 2017

Abstract

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.

Type
Research Article
Copyright
Copyright © Centre for European Legal Studies, Faculty of Law, University of Cambridge 2014

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43 Ibid.

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.

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59 Ibid, 4.

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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.

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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.

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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 [1957] 1 WLR 582), although it has gradually become less so (Bolitho v City and Hackney Health Authority [1997] 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.

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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.

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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.

124 Ibid.

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.

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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.

140 Global Forum for Health Research, The 10/90 Gap in Health Research (Geneva, GFHR, 1999)Google ScholarPubMed.

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.

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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.

155 Sell, S, Private Power, Public Law: The Globalization of Intellectual Property Rights (Cambridge, Cambridge University Press, 2003)CrossRefGoogle Scholar.

156 Kerry, VB and Lee, K, ‘TRIPS, the Doha Declaration and Paragraph 6 Decision: What are the Remaining Steps for Protecting Access to Medicines?’ (2007) 3 Global Health 3 CrossRefGoogle ScholarPubMed.

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.

162 WHO Commission on Intellectual Property Rights, ‘Innovation and Public Health, Public Health Innovation and Intellectual Property Rights’ (Geneva, WHO, 2006)Google ScholarPubMed.

163 Cf the idea that rights are also a risk: Murphy, T, ‘Taking Revolutions Seriously: Rights, Risk and New Technologies’ (2009) 16 Maastricht Journal of European and Comparative Law 15 CrossRefGoogle Scholar.

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