Fecal microbiota transplantation has demonstrated efficacy and is increasingly being used in the treatment of patients with recurrent Clostridium difficile infection. Despite a lack of high-quality trials to provide more information on the long-term effects of FMT, there has been great enthusiasm about the potential for expanding its applications. However, FMT presents many serious ethical and social challenges that must be addressed as part of a successful regulatory policy response. In this article, we draw on a sample of the scientific (...) and bioethics literatures to examine clusters of ethical and social issues arising in five main areas: informed consent and the vulnerability of patients; determining what a “suitable healthy donor” is; safety and risk; commercialization and potential exploitation of vulnerable patients; and public health implications. We find that these issues are complex and worthy of careful consideration by health care professionals. Desperation of a patient should not be the basis for selecting treatment with FMT, and the patient's interests should always be of paramount concern. Authorities must prioritize development of appropriate and effective regulation of FMT to safeguard patients and donors, promote further research into safety and efficacy, and avoid abuse of the treatment. (shrink)

In a world surrounded by smart objects from sensors to automated medical devices, the ubiquity of ‘smart’ seems matched only by its lack of clarity. In this article, we use our discussions with expert stakeholders working in areas of implantable medical devices such as cochlear implants, implantable cardiac defibrillators, deep brain stimulators and in vivo biosensors to interrogate the difference facets of smart in ‘implantable smart technologies’, considering also whether regulation needs to respond to the autonomy that such artefacts carry (...) within them. We discover that when smart technology is deconstructed it is a slippery and multi-layered concept. A device’s ability to sense and transmit data and automate medicine can be associated with the ‘sting’ of autonomy being disassociated from human control as well as affecting individual, group, and social environments. (shrink)

In its governance activities for genetic resources, the international community has adopted various approaches to their ownership, including: free access; common heritage of mankind; intellectual property rights; and state sovereign rights. They have also created systems which combine elements of these approaches. While governance of plant and animal genetic resources is well-established internationally, there has not yet been a clear approach selected for human genetic resources. Based on assessment of the goals which international governance of human genetic resources ought to (...) serve, and the implications for how they will be accessed and utilised, it is argued that common heritage of mankind will be the most appropriate approach to adopt to their ownership/control. It does this with the aim of stimulating discussion in this area and providing a starting point for deeper consideration of how a common heritage of mankind, or similar, regime for human genetic resources would function and be implemented. (shrink)

There are several good reasons for the UK Department of Health to recommend the appraisal of bevacizumab for the treatment of eye conditions by the National Institute for Health and Clinical Excellence. These reasons will extend to other drugs when similar situations arise in the future.

Genetic resources are a key resource for much biomedical research. Pathogenic genetic resources are of value in the identification, surveillance, understanding, and development of vaccines, treatments, and other responses to major public threats such as pandemic influenza outbreaks. Significant attempts have been made to improve the international governance of infectious disease over the last decade, but the handling of pathogenic genetic resources remains contentious and problematic. The need to address the deficiencies in current arrangements (e.g., the World Health Organization's Pandemic (...) Influenza Preparedness Framework) is urgent because future outbreaks are likely to revert to the past situation in which developed states secured vaccine supplies for their own populations while leaving developing countries vulnerable to the pandemic. Thereby, the collaboration of developed countries with vital international systems such as the Global Influenza Surveillance and Response System is disincentivized. The current international approach to pathogenic genetic resources is based on the sovereign rights of states and access and benefit-sharing arrangements that stem from those rights. While this approach is consistent with international rules on other types of genetic resources, herein I argue that this is an inappropriate approach to pathogens on both political (serving public health goals) and ethical grounds (e.g., equity and justice). Instead I argue for a (modified) common heritage approach to pathogenic genetic resources, based on their intrinsic qualities (e.g., rapid mutation, easy transmissibility) and their value to global efforts to respond to disease outbreaks. I will further argue for de-linking access to these resources from benefit-sharing requirements; explaining that while there are strong justifications for both, their linkage (particularly for pathogenic genetic resources) is problematic and detrimental to the achievement of its intended goals (i.e., ensuring equitable benefit-sharing in return for access being granted). (shrink)