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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


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.

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

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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.

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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’: 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.

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.

48 Comparisons between the EU and FDA include ‘EMA Bests FDA in 2013 New Drug Approval Numbers’:; LJ Howie and others, ‘A Comparison of FDA and EMA Drug Approval: Implications for Drug Development and Cost of Care’ (2013) Oncology

49 For an overview see ‘Authorisation procedures for medicinal products’:

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:

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.

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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’:

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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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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:

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:

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’:

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:!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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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).

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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.

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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.