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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.
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- Copyright © Centre for European Legal Studies, Faculty of Law, University of Cambridge 2014
References
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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.
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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.
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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.
139 www.edctp.org.
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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.
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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.