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Contents

• Letter from the Editor Michael Weintraub
  
• Bioethics in Brief Leila Glass, Tuua Ruutiainen
  
• Octuplets Case Study Armin Gollogly
  
• Induced Pluripotent Cells Vineet Patil
  

Articles

• The TRIPS Agreement and Developing Countries by Markley Foreman Read Abstract

  In 2005, the Indian government issued the Patents (Amendment) Act 2005 which catapulted the country into a new global system of trade and legal governance. This legislation deviated from India’s historically lenient system of intellectual property by strengthening the country’s minimum standards for patent protection in compliance with a new global agreement: Trade Related Aspects of Intellectual Property (TRIPS). With its large generic pharmaceutical industry and significant burden of infectious and chronic disease, India is a particularly unique case where patent law has had and will continue to have far-reaching consequences. Indeed, patent protection or lack thereof is literally a matter of life or death for developing countries like India where large populations depend on affordable access to essential or life-saving medications. TRIPS is administered by the World Trade Organization (WTO) and sets minimum standards for intellectual property rights (IPR) in member countries. The Agreement includes five major public health “flexibilities” which aim to alleviate the possible negative effects of strict patent law on access to affordable medicines in developing countries The five most important flexibilities include: transition periods for TRIPS compliance, compulsory licenses, parallel imports, experimental use of patented products or processes, and the Bolar exception (or use of a patented product or process for regulatory approval). While India’s incorporation of these flexibilities into domestic legislation has been complete, there is question as to whether the TRIPS flexibilities are capable of fully addressing the health needs of the Indian population. By incorporating all of the major flexibilities that accommodate public health, India took every measure possible, within the constraints, to afford its people secure access to their health needs. Philosopher Thomas Pogge suggests two major alternatives to the TRIPS model for research incentives: the differential- pricing strategy and the public-goods strategy. These alternatives, however, are inconsistent with the currently accepted rules and norms of global trade. Continued legislative success for TRIPS and global equity in access to essential medicines will depend on the interpretation and application of TRIPS-related legislation by Indian courts and enforcement bodies.

• The Opt-out Organ Donation System by Emily Frydendall Read Abstract

  Currently, the US is facing an enormous organ shortage and many citizens are dying because they have not received necessary organ transplants. One possible solution to this problem is for the US to switch from opt-in organ donation, in which organ donors must actively commit themselves to the donor pool, to an opt-out organ donation system in which everyone is presumed to be part of the donor pool unless they have specifically opted out. However, many individuals object to switching to the opt-out system due to varying considerations of autonomy, nonmaleficence, and justice. This paper analyzes the merits of these arguments and concludes that the US could substantially and ethically reduce the organ shortage by adopting an opt-out system.

• The Ethical Repercussions of Patenting Human Genes by Stephanie Hylmar Read Abstract

  The issue of human gene patenting is a vehemently debated topic which questions the possession of biotechnological knowledge. A broad scope of bioethical concerns must be carefully considered when discussing the patenting of human genetic material, especially that which deals with human health and disease. At the center of these concerns is the question surrounding the ownership of human tissue; do we own our own bodies or does someone else? Also, human gene patenting is heavily impacted by the classification of human genes as inventions of human ingenuity or discoveries which are products of nature and are shared heritage of mankind. In debating these concerns human dignity must be observed while maintaining the possibility of furthering biotechnological innovation. The Canadian Biotechnology Advisory Committee has put forth a set of guiding principles which could effectively serve as an international standard to establish whether patenting of human genes should continue as a legitimate practice or be banned once and for all.

• The Chinese Primary Care System by Thomas Hou Read Abstract

  There has been much interest in China and abroad in the Chinese health care system and legal systems. To date, however, there has not been adequate study tying legal reform and health care reform in China. This paper seeks to bridge those disciplines by studying the most crucial aspect of the Chinese health care system: the primary care system. The author examines recent efforts at reform in primary care, and explores some major legal and policy issues relating to both national and local governments’ efforts at reform, as well as citizens’ efforts using the expanded power of the legal system. For this study, the author looks at other academic and government studies on China’s health care system and legal system. He also attended and reviewed presentations and interviewed professors with direct knowledge of the situation in China. The research shows that the Chinese primary care system, and in fact its entire health care system, is undergoing tremendous change and faces similar problems as the United States. National-local government differences in responsibilities hamper efforts at reform while changes in administrative law have empowered citizens to a degree, although they still depend on the government to take action. Overall, China will need to find a culturally acceptable and practically workable balance between national and local power, and between governmental and citizen responsibility, to achieve health care reform.

• The Ethics of Condition and Circumstance by Ari Schriber Read Abstract

  Rapid development of biotechnology challenges long-held tenets of religious knowledge. Especially in topics dealing directly with the ethics of human life, the availability of technology allows for the proliferation of scientifically based claims for which only speculation formerly sufficed. Islam places great emphasis on the divine nature of creation as manifested through human existence. As a faith that has given way to significant juridical interpretation, Islam provides many laws and doctrines to help guide humans through life in deference to God. However, when faced with an ethical issue such as abortion—one for which there is no explicit command in the scripture—modern Muslims have yet to put forth a universally applicable stance that theology can definitively substantiate in light of recent scientific advancements. As such, in the following paper, I attempt to examine why one of the largest faiths in the world has encountered such difficulty in reconciling its conception of life’s creation with knowledge about fetal development only recently acquired (relative to the religion’s over 1400 years of existence). I discuss the complexities in the way Muslims historically handled abortion that have raised ethical concern now that scientists understand human embryonic development . Thus, when I consider the traditions (not necessarily the theology) and their inherent conflicts with quantifiable science, I try to find a way that Muslims can reconcile the circumstances giving rise to abortion with the reverence for human life paramount in Islam.

• Computers in Healthcare by Julia Yinxin Zhu Read Abstract

  Transforming paper-based health records to electronic health records (EHRs) has been an evolution in the field of healthcare in the past 15 years. The implementation of the EHRs has had a profound impact at many levels in Canadian and many other nations’ healthcare systems. This paper explores and analyzes both the positive and negative effects that EHRs would bring. The definition, scope, motivation and risks of implementing EHR systems have been carefully examined. Some concerns over privacy, confidentiality, security, as well as technology dependencies and reliability are also explored and discussed in this paper. Enhancing overall healthcare service and research outcomes has enhanced the progress of EHR. However, on the way to successful EHR implementation, a number of outstanding issues need to be resolved, including integration with old systems and interoperability among different healthcare institutions. To overcome the hurdles faced at the national, organizational and technical level, concerted actions by all healthcare stakeholders, policy makers, governments and other parties are needed.

• Towards a More Ethical Medical Environment by Jeremy Schifberg Read Abstract

  Despite their short history, hospital ethics committees (HECs) have quickly become common in hospitals across the country. While there is a clear consensus on the value of these bodies, no such clarity exists regarding their ideal structure, function and role. Moreover, although HECs are present in hospitals nationwide, recent studies have indicated that they are utilized at surprisingly low rates. A lack of discussion and agreement about how HECs should function may underlie this phenomenon, thus this article aims to outline the optimal roles and functions of HECs. By means of an analysis of the three most common functions brought up in discussions of HECs – education, policy development and case consultation – this paper seeks to answer two distinct but related questions: First, should the chief purpose of HECs be to attempt to determine the moral or ethical resolution to cases, to establish a procedural framework or guidelines to make reasonable policy decisions, or both? And second, should the chief role of HECs be an advisory role or an activist, decision-making role? It is concluded that HECs should have as their primary function the goals of educating and of helping to resolve cases in a moral or ethical manner while serving a solely advisory role.

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