Procreative liberty in the era of genomics.

I. INTRODUCTION: ETHICAL AND POLICY CHALLENGES OF THE GENOME Twentieth century biology began with the rediscovery of Gregor Mendel's work on peas and ended with the sequencing of the human genome. In between came Thomas Morgan's studies of fruit flies, the grand synthesis between genetics and evolutionary biology in the 1930s, and Watson and Crick's publication in 1953 of the double helix structure of deoxyribose nucleic acid ("DNA"), the substance in the nucleus of cells, which carries the genetic code of all eukaryotic life.1 The genetics of the second half of the century focused on learning how DNA coded for proteins, how to splice, clone, and recombine pieces of DNA, and how genetic mutations caused disease. In the late 1980s, a project to identify the actual sequence of all 3.2 billion base pairs of the human genome began.2 In June 1999, President Clinton and Prime Minister Blair announced that a working draft of the human genome was complete, with the final completed draft to 99.9% accuracy expected in May 2003, fifty years after the publication of Watson and Crick's landmark paper.3 This remarkable achievement now provides scientists with the tools for understanding the molecular details of how living cells function and evolve, and thus the means for diagnosing, treating, and preventing many diseases. It will also lead to applications in reproduction, in personal and kinship identity, and possibly in social control. Increasing "geneticization" of medical, reproductive, and social spheres of life will bring many benefits, but may also lead to public and private misuse, and new forms of power over individuals.4 A special threat is genetic reductionism and its effect on how humans view themselves and their place in the universe.5 Coming to grips with the social implications of human genomic knowledge presents a series of diverse, but related, challenges about how to make use of genetic information in human affairs in ethically, legally, and socially acceptable ways. One major group of issues concerns ownership and control rights in the genome. Researchers need access to human DNA and patient medical records to identify genes, and to develop drugs and treatments based on them. Intellectual property rights in genes or gene products may also be necessary to spur investment in genomic research. At the same time, the privacy rights of individuals in their bodily tissue, DNA, and medical records demand strong protection. A different set of issues arises from the many potential medical uses of genomic information. Genomics will play a major role in understanding the mechanics of disease, and in designing drugs and treatments to prevent and treat disease. Screening individuals or populations for genetic susceptibility or late-onset conditions, so that prevention may occur, will become much more common. Pharmacogenomics-genomic factors influencing drug metabolism6-may enable physicians to prescribe drugs tailored to a patient's genotype.7 But unraveling the body's genetic secrets and turning them into effective therapies poses a major scientific challenge. As Dr. Francis Collins, the director of the National Human Genome Research Institute, has put it, genomics "will occupy science and medicine for the next 50 or 100 years."8 A third set of issues-the use of genomic knowledge in reproduction-shows how socially and morally complicated genomic applications can be. Because genes are inherited systems of information passed on to progeny,9 genomic knowledge increases the ability to predict or even control the genes of offspring. Persons planning reproduction might want to know something about their genetic makeup or that of their embryos or fetuses before they conceive, bear, or give birth to offspring. While much of the resulting control will operate by excluding undesirable genomes, at some point, attempts to rewrite or engineer sections of the genetic code of prospective offspring may also occur. …