'Clinical Trials Abroad: The Marketable Ethics, Weak Protections and Vulnerable Subjects of EU Law' (Queen's University Belfast Law Research Paper No. 1) by Mark Leslie Flear
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 the latter as a fix for public health problems. These are 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 and 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.
'A 'Duty' to Continue Selling Medicines' by William M Janssen in (2014) 40
American Journal of Law and Medicine comments
With disappointing frequency, shortages occur in the supply of prescription pharmaceuticals. Sometimes, those shortages persist for months (even years), and can implicate the only known medicine to treat a life-threatening medical condition. Sometimes, those shortages may also be due to avoidably negligent decisions in manufacture. Twice in the past two years, seriously ill patients — confronting just such medicine supply shortages — have resorted to the courts, demanding a judicial remedy for negligently caused supply interruptions to critically needed medicines. In doing so, they have asserted a bold litigating position: the law ought to impose upon drug manufacturers a legal duty to continue selling their medicines. In other words, once a pharmaceutical manufacturer enters a medicine market, it is obligated by law to remain there and preserve perpetually its medicine’s supply. This claim of compelled-access-to-pharmaceuticals pushes to the very frontier of drug law in America.
This Article begins by tracing the two cases (one in Utah, the other in Florida) that confronted these creative compelled-access-to-medicines arguments. Earlier cases, resolving a distinctive but thematically similar compelled-access argument in the context of experimental drugs, are introduced as well. The discussion explains how each claim lost in court. The Article next performs an independent survey of a wide range of legal theories — in constitutional principle, enacted law, regulatory law, and case law — that could be cited as alternative potential sources for imposing a duty on manufacturers to continue selling their drugs. It demonstrates that none is likely to be a credible source for that duty. Finally, the Article examines the competing policy considerations that would be implicated by “inventing” such a duty, finds that a judicial invention is unwise, but offers a potential statutory amendment designed to strike a sound balance between the legitimate proprietary and autonomy interests of manufacturers and the health and survival interests of critically ill patients.
