The professional regulatory system known as medical ethics has been one of the most visionary and socially valuable creations of the medical profession. Its beneficial influence has extended beyond physician/patient relations, to the shaping of many key humanistic and egalitarian features of the world’s legal and political institutions. The continued existence of medical ethics as a professionally influential normative system, however, is being challenged by international human rights. The UNESCO Universal Declaration on Bioethics and Human Rights, is likely to be (...) an important point of intersection in this process. (shrink)

The United Nations Scientific, Education and Cultural Organisation (UNESCO) Universal Declaration on Bioethics and Human Rights (UDBHR) expresses in its title and substance a controversial linkage of two normative systems: international human rights law and bioethics. The UDBHR has the status of what is known as a ‘non-binding’ declaration under public international law. The UDBHR’s normative foundation within bioethics (and association, for example, with virtue-based or principlist bioethical theories) is more problematic. Nonetheless, the UDBHR contains socially important principles of technology (...) transfer and transnational benefit (articles 14, 15 and 21). This paper is one of the first to explore how the disciplines of bioethics and international human rights law may interact in the UDBHR to advance the policy relevance and health impact of technology transfer and transnational benefit principles. It investigates their normative ancestry in the UDBHR, as well as relevant conceptual differences between bioethics and public international law in this respect and how these may be relevant to their conceptual evolution and application. (shrink)

Thomas Alured Faunce, College of Law, Fellows Road, Acton, Canberra ACT 0200, Australian National University, Fax: 61 2 61253971, Email: Thomas.Faunce{at}anu.edu.au ' + u + '@' + d + ' '//-->This paper sets out to analyse three different academic proposals for addressing the needs of the poor in relation to new, rather than ‘essential’ medicines. It focuses particularly on research and development prize funds, a health impact fund system and a multilateral treaty on health technology cost-effectiveness evaluation and competitive tender. (...) It compares the extent to which each responds to the ‘market fundamentalist’ philosophy and begins to analyse their respective strengths and weaknesses. CiteULike Connotea Del.icio.us What's this? (shrink)

This article explores a unique opportunity for shaping public health law and policy to reflect a greater balance between public and private goods in two areas of primary concern to human well-being: medicine and human biosecurity. This opportunity is presented both by the rapid changes likely to occur in these areas as a result of nanotechnology and the fact that multinational corporate actors have not yet had the opportunity to use their well-honed techniques of governance influence to modify public health (...) policy and law in this area to their own narrowly focused advantage. Such a rare opportunity to rethink some fundamental assumptions about a regulatory framework for globally important health issues in advance is one reason why issues concerning nanotechnology regulation in medicine and human biosecurity should have considerable interest to health law and policy scholars. (shrink)

This paper considers how best to approach dilemmas posed to global health and biosecurity policy by increasing advances in practical applications of nanotechnology. The type of nano-technology policy dilemmas discussed include: expenditure of public funds, public-funded research priorities, public confidence in government and science and, finally, public safety. The article examines the value in this context of a legal obligation that the development of relevant public health law be calibrated against less corporate-infuenced norms issuing from bioethics and international human rights.

Much contemporary nanotoxicology, nanotherapeutic and nanoregulatory research has been characterised by a focus on investigating how delivery of engineered nanoparticles (ENPs) to cells is dictated primarily by components of the ENP surface. An alternative model, some implications of which are discussed here, begins with fundamental physicochemical research into the interaction of a dynamic nanoparticle-protein corona (NPC) with biological systems. The proposed new model also requires, however, that any such fresh NPC physicochemical research approach should involve integration and targeted collaboration from (...) the earliest stages with nanotoxicology, nanotherapeutics and nanoregulatory expertise. The justification for this integrated approach, we argue, relates not just to efficiency and promotion of innovation, but to an acknowledgement that public-funded basic physicochemical research in particular should now be accepted to incorporate strong higher order public goods elements from its inception, not merely after product development at the technology transfer stage. Issues, in other words, such as university research co-operation, commercialization and intellectual property (IP) protection, safety and cost-effectiveness regulatory assessment, as well as technology transfer should not be viewed as second tier considerations even in a ‘blue sky’ NPC basic research agenda. (shrink)

The United Nations Scientific, Education and Cultural Organisation (UNESCO) has commenced drafting a Universal Bioethics Declaration. Some in the relevant UNESCO drafting committee have previously desired to restrict its content to general principles concerning the application (but not necessarily the goals) of science and technology. As potentially a crucial agenda-setting statement of global bioethics, however, it is arguably important the Universal Bioethics Declaration transparently address major bioethical dilemmas in the field of public health, such as universal access to affordable, essential (...) medicines. Article 13 (Social Responsibility) of the Preliminary Draft Universal Bioethics Declaration states: ‘Any decision or practice shall ensure that progress in science and technology contributes, wherever possible, to the common good, including the achievement of goals such as: (i) access to quality health care and essential medicines, including for reproductive health and the health of children.’Cost effectiveness pricing systems, such as that most notably used in Australia’s Pharmaceutical Benefits Scheme (PBS), arguably represent one of the most scientifically effective mechanisms whereby public monies may be utilised to assist in the provision of medicines for the common good. They contain two essential elements: first, a process of scientific evaluation of objectively demonstrated therapeutic significance, and then, a fiscal lever (the government reimbursement price) attached to that evaluation.It is now well established that the US Pharmaceutical Research and Manufacturers Association (Pharma), through the assistance of the US Trade Representative (USTR), saw the Australia United States Free Trade Agreement (AUSFTA) as an opportunity to fulfill a legislative mandate to ‘eliminate ’ the cost-effectiveness pricing system in Australia’s PBS. One of the most remarkable features of the arguments raised against the PBS in this context was the fact that they made almost no reference to the normative discourse of bioethics or international human rights. Provisions such as Article 13 in UNESCO’s Universal Bioethics Declaration, although they will create no immediate obligations under international law, may play an extremely valuable role in legitimising the use of bioethical and human rights concepts in access to medicines debates surrounding multilateral and bilateral international trade deals such as the AUSFTA. (shrink)