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"SYNTHETIC BIOLOGY AND THE CREATION OF HUMAN ORGANS: SHOULD COMMODIFICATION OF MAN-MADE BODY PARTS BE LEGALIZED?

" Prabhkaran S. Bedi Synthetic biology is the fusion of biology and engineering with the goals of design and construction of new biological entities such as enzymes, genetic circuits, and cells or the redesign of existing biological systems. The field builds on years of major advances in cell, molecular and systems biology and proponents claim that synthetic biology will transform biology the same way that synthesis transformed chemistry and the integrated circuit transformed computing. What makes synthetic biology so different from traditional disciplines such as cellular and molecular biology is the emphasis on design and construction of core components (parts of enzymes, genetic circuits, metabolic pathways, etc.) that can be modeled, understood, and tuned to meet specific criteria, and the assembly of these smaller parts and devices into larger integrated systems to solve specific problems. The scare availability of human transplant organs and the deaths that occur as a result are some of the many problems for which synthetic biology can provide meaningful solutions. At its current stage of development, synthetic biology shows immense potential for the growth of complex and vital human organs such as the liver, kidney and heart. While this potential may be about a decade from realization, basic organs have already been successfully created by researchers. For example, in 2008, a team of European physicians and scientists lead by Dr. Paolo Marcchiarini, a Swedish surgeon, performed the successful transplant of a human stem cell grown trachea (windpipe) in a 36-year-old African man suffering from late stage tracheal cancer. Indeed, the ability for man to create human organs from scratch will, without a doubt, have positive effect on the availability of human organs for transplant and help us save countless lives. Therefore it is no surprise that most of the current regulatory focus is on moving research along in the safest way possible so science can eventually get to the point where the creation of complex organs becomes commonplace. However, despite the fact that this “point” is already on the horizon, there is very little government or academic commentary on the regulation of synthetically created human organs. This presentation will examine the most effective ways to regulate the future procurement process for man-made human organs. I will present an overview of the current and often criticized “natural” organ procurement system; specifically address challenges that synthetic organs will present to current system and propose a solution to address these issues. Some important issues to be addressed include:      How far along is science of synthetic biology from giving us the ability to grow complex human organs in the lab? How and why are synthetic organs any different from “natural” organs? Once creation of synthetic organs becomes commonplace, should we allow for the commodification of these new entities? What legal and regulatory actions must the government take today so that it can properly oversee the future synthetic organ market? What challenges will the government face in the regulation of the synthetic organ market?