The Journal of law, medicine & ethics : a journal of the American Society of Law, Medicine & Ethics
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This paper discusses exceptional circumstances under which patients outside of clinical trials are likely to receive innovative stem cell-based interventions. These circumstances involve: (1) stem cell interventions not initially amenable to a clinical trials approach; (2) expanded access to investigational stem cell products ("compassionate use"); and (3) off-label uses of FDA approved stem cell products. This paper proposes a new approach to regulating these exceptional cases.
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The time is ripe for innovation in global health governance if we are to achieve global health and development objectives in the face of formidable challenges. Integration of global health concerns into the law and governance of other, related disciplines should be given high priority. This article explores opportunities for health policymaking in the global response to climate change. ⋯ Although scientific research has pointed to the interdependence of the global environment and human health, policymakers have been slow to integrate their approaches to environmental and health concerns. A robust response to climate change will require improved integration on two fronts: health concerns must be given higher priority in the response to climate change and threats associated with climate change and environmental degradation must be more adequately addressed by global health law and governance. The mitigation/adaptation response paradigm developing within and beyond the United Nations Framework Convention on Climate Change provides a useful framework for thinking about global health law and governance with respect to climate change, environmental degradation, and possibly other upstream determinants of health as well.
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This article argues from a South African perspective that national experience in attempting to fulfil the right to health supports the need for an international framework. Secondly, we suggest that this framework is not just a matter of good choice or even of justice but of a direct legal duty that falls on those states that have consented to operate within the international human rights framework by ratifying key treaties such as the International Covenant on Economic Social and Cultural Rights (ICESCR), the Convention on the Elimination of all forms of Discrimination Against Women (CEDAW), and the Convention on the Rights of the Child (CRC). States can either accept this duty or face with growing pressure from those who believe in global social justice to find lasting solutions to the terrible inequities in global health standards.
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Legally defining "death" in terms of brain death unacceptably obscures a value judgment that not all reasonable people would accept. This is disingenuous, and it results in serious moral flaws in the medical practices surrounding organ donation. Public policy that relies on the whole-brain concept of death is therefore morally flawed and in need of revision.
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This paper considers how we can conceptualize a "global response" to chronic, non-communicable diseases (NCDs)--including cardiovascular disease, cancer, diabetes, and tobacco-related diseases. These diseases are the leading cause of death and disability in developed countries, and also in developing countries outside sub-Saharan Africa. The paper reviews emerging and proposed initiatives for global NCD governance, explains why NCDs merit a global response, and the ways in which global initiatives ultimately benefit national health outcomes. ⋯ It is not yet clear what institutional mechanism, if any, will rise above the sea of surrounding initiatives to play this global role. This paper therefore aims to provide a conceptual map for making sense of what individual initiatives contribute to global governance. This map also draws attention to the distinctively "global" public health functions that a global response to NCDs should seek to discharge.