This paper addresses an apparent dilemma that must be resolved in order to respond ethically to global climate change. The dilemma can be presented as follows. Responding ethically to global climate change requires technological innovation that is accessible to everyone, including inhabitants of the least developed countries. Technological innovation, according to many, requires strong intellectual property protection, but strong intellectual property protection makes it highly unlikely that patent-protected technologies will be accessible to developing countries at affordable prices. Given this, responding (...) ethically to global climate change is highly unlikely. I argue that this apparent dilemma – which I call ‘the patent dilemma in global climate change’ – should be taken seriously. I discuss a number of possibilities for resolving it, and I argue that any acceptable strategy must satisfy the criteria of near-term feasibility and non-paternalism. Finally, I propose a multi-pronged, multi-tiered strategy that meets these conditions. (shrink)

The main question explored by the book is: How can cross-border access to human genetic resources, such as blood or DNA samples, be governed in such a way as to achieve equity for vulnerable populations in developing countries? The book situates the field of genomic and genetic research within global health and research frameworks, describing the concerns that have been raised about the potential unfairness in exchanges during recent decades. Access to and sharing in the benefits of human biological resources (...) are aspects not regulated by any international legal framework such as the Convention on Biological Diversity, which applies only to the exchange of plants, animals and microorganisms, as well as to associated traditional knowledge. Examples of genetic research perceived as exploitative are provided in order to illustrate the legal vacuum concerning the global governance of human genetic resources. The main conclusions drawn from the legal and ethical analysis are: - Benefit sharing is crucial in order to avoid the exploitation of developing countries in human genetic research. - With functioning research ethics committees, undue inducement is less of a concern in genetic research than in other areas of medical research (e.g. clinical trials). - Concerns remain over research involving indigenous populations; accordingly, recommendations are provided. In drawing these conclusions, the book addresses in detail a highly pressing topic in global bioethics and international law. In this regard, it combines bioethical arguments with jurisprudence, in particular with reference to the law of equity and the legal concepts of duress (coercion), unconscionable dealing, and undue inducement. (shrink)

Developing and applying a framework for understanding the complexities of economic and legal considerations in two recent Supreme Court rulings was the focus of this research. Of especial concern was the protection of intellectual property in the pharmaceutical industry. Two cases from 2013 were selected: FTC v. Activis and Association for Molecular Pathology v. Myriad Genetics, Inc.. Part of the rationale for the selection was the importance of the Supreme Court rulings and the importance of the pharmaceutical sector. A qualitative (...) content analysis of the Court’s reported decision in each case was analyzed. Since ethical considerations may or may not be consistent with efficiency considerations of plaintiffs, defendants, or the courts, both efficiency and ethical arguments were included. Equally important to the understanding of the economic and ethical issues in the two above- mentioned cases was the development of a rationale for including and excluding a variety of ethical theories, ultimately influenced by Markkula Center For Applied Ethics Of Santa Clara University and Schumann :93–111, 2001). The refinement and use of a levels analysis approach portrays societal, organizational, and individual impacts, and allows for deeper understanding of litigated cases, irrespective of the country in which the litigation takes place :385–393, 2004; Foss et al., J Manag Stud 47:455–482, 2010). A rationale for this framework is the societal and organizational impacts on the myriad of stakeholders in the pharmaceutical sector. We suggest that this framework can be applied to other industries and other complex conflicts among stakeholders as well. (shrink)

In a widely cited 2003 article, DiMasi, Hansen, and Grabowski estimated the cost of pharmaceutical research and development to be $1.1 billion per new medicine coming onto the market in 2001. They also estimate that this cost is going up at a real rate of 7.4% annually. According to these estimates, the innovation cost per new medicine today is about $2.1 billion or $2.65 billion.