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)

Conflicts between the ethical values of an organisation and the ethical values of the employees of that organisation can often lead to conflict. When the ethical values of the employee are considerably higher than those of the organisation the potential for catastrophic results is enormous. In recent years several high profile cases have exposed organisations with ethical weaknesses. Academic medical institutions have exhibited such weaknesses and when exposed their employees have almost invariably been vindicated by objective inquiry. The mechanisms that (...) work to produce such low ethical standards in what should be exemplary organisations are well documented and have been highlighted recently. The contribution of elements of medical training in eroding ethical standards of medical students have also been emphasised recently and strategies proposed to reduce or reverse this process. The ability to rapidly change the ethical and professional culture of graduate medical trainees may help to deal with some of the perceived problems of declining ethical standards in academic medicine. (shrink)

Healthcare whistle blowing, despite the benefits it has brought to healthcare systems in many developed countries, remains generally regarded as a pariah activity by many of the most influential healthcare professionals and regulatory institutions. Few if any medical schools or law department health law and bioethics classes, teach whistle blowing in a formal sense. Yet without exception, public inquiries initiated by healthcare whistle blowers have validated their central allegations and demonstrated that the whistle blowers themselves were sincere in their desire (...) to implement the fundamental virtues and principles of medical ethics, bioethics and public health law. In many jurisdictions, the law, this time remarkably in advance of professional opinion, has offered legislative protection for reasonable allegations of whistleblowers made in good faith and in the public interest concerning a substantial and imminent threat to public safety. One reason for this paradoxical position, explored here, is that healthcare whistle blowing lacks a firm virtue-based theoretical bioethical and jurisprudential foundation. The hypothesis discussed is that the lack of this bioethical and jurisprudential substrate has contributed to a situation where healthcare whistle blowing suffers in terms of institutional support due to its lack of academic legitimacy. This article commences the process of redressing this imbalance by attempting to lay the theoretical foundations for healthcare whistle blowing. As a case study, this article concludes by discussing the Personal and Professional Development course at the ANU Medical School where healthcare whistle blowing is a formal part of a virtue-based curriculum that emphasises the foundational importance of conscience. Illustrative elements of that program are discussed. (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 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.

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)

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)

This paper examines the recent UK House of Commons Health Committee report on the Influence of the Pharmaceutical Industry in relation to its findings and recommendations concerning access to medicines, and in particular the continuance of cost effectiveness or reference pricing. This mechanism of bargaining down the price of drugs on social justice grounds recently has been targeted by the US Department of Commerce as an unjustifiable non-tariff barrier to trade that should be eliminated in all OECD countries. Concerns have (...) been raised that certain provisions in the AUSFTA may have been designed to achieve this end, in defiance of norms of democratic legitimacy, moral responsibility and the international right to health. Here we examine some implications of the UK House of Commons Report for the PBS in Australia. (shrink)

The ‘Precautionary Principle’ provides a somewhat ill-defined guide, often of uncertain normative status, for those exercising administrative decision-making power in circumstances where that may create potential risks to human health or the environment. This paper seeks to explore to what extent the precautionary principle should have been and was in fact utilised by the Australian Therapeutic Goods Administration (TGA) in its decision to approve the marketing of sunscreens containing titanium dioxide (TiO2) and zinc oxide (ZnO) in nanoparticulate form. In particular, (...) this article assesses to what extent better application of that principle might have altered the TGA’s decision that TiO2 and ZnO ENPs in sunscreens do not require new safety testing, because they are considered to be functionally equivalent to their bulk counterparts. (shrink)

Abstract Environmental and public health-focused sciences are increasingly characterised as constituting an emerging discipline—planetary medicine. From a governance perspective, the ethical components of that discipline may usefully be viewed as bestowing upon our ailing natural environment the symbolic moral status of a patient. Such components emphasise, for example, the origins and content of professional and social virtues and related ethical principles needed to promote global governance systems and policies that reduce ecological stresses and pathologies derived from human overpopulation, selfishness and (...) greed—such as pollution, loss of biodiversity, deforestation and greenhouse gas emissions, as well as provide necessary energy, water and food security. Less well explored in this context, however, is the ethics that should underpin global use of emerging technologies such as nanotechnology as forms of planetary therapeutics. Nanotechnology may be particularly important, for instance, as a mechanism for improving upon photosynthesis and engineering it into human structures for localised production of carbon-neutral hydrogen based-fuel and carbohydrate-based food and fertilizer. Artificial photosynthesis, because of its unique and widespread public and environmental benefits in this period of human history, may even be termed the moral culmination of nanotechnology, assisting this planet to move beyond the Anthropocene epoch to that of the Sustainocene. This paper explores practical steps towards planetary nanomedicine involving governance of artificial photosynthesis, including a UNESCO Universal Declaration on the Bioethics and Human Rights of Natural and Artificial Photosynthesis (Global Solar Fuels and Foods ). Content Type Journal Article Category Original Paper Pages 1-13 DOI 10.1007/s11569-012-0144-4 Authors Thomas Faunce, College of Medicine, Biology and the Environment and College of Law (joint Appointment), Australian National University, Acton, Australia Journal NanoEthics Online ISSN 1871-4765 Print ISSN 1871-4757. (shrink)