The Human Genome Project in the United States: a perspective on the commercial, ethical, legislative and health care issues.

The Human Genome Project represents a government supported effort to map and sequence the human genome. Governmental support for the Project should include increased emphasis on grants and contracts to industry. This is particularly true for small highly innovative biotechnology companies that can rapidly integrate and use technology as a base for product development. Private industry must be integrated as a partner into the Project, as it will be in Japan and Europe. There is a consensus in industry that the Genome Project is, at this stage at least, a science research project funded by government and not, at present, a commercial project. It is not seriously expected to have any substantial widespread commercial impact in the near future. The ultimate commercial benefits of the Human Genome Project, in terms of definable health care products, may not be realized until well into the next century. Yet, there are a few companies for which the Genome Project affords immediate commercial opportunities in certain niche areas. The Genome Project can be expected to have a significant impact upon medical knowledge and treatment. Though the Genome Project is just beginning, much of the type of medical knowledge expected to be gained from the Project is already present and even being exploited, albeit on a small scale. The application of genetic understanding to practical applications raises ethical, medical and legal issues central to the Genome Project. Unfortunately, emotion and sensationalism sometimes dominate and prevent a constructive discussion of ethical and social issues pertaining to genetics. To answer public concerns about human gene transfer experiments, the medical and biotechnology communities must constructively discuss the medical realities, the benefits to human health and the adequacy of the current governmental oversights. These presentations must be understandable by the lay public and must address their fears. Failure to assuage public fears and concerns, no matter how abstract or unrealistic they may be to the medical/scientific community, will lead to increased governmental controls and regulatory burdens.