Germline gene therapy: its time is near.

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For almost two decades, bioethicists, legal scholars and writers in the popular press have debated the ethics and consequences of gene engineering and gene therapy. Much of the discussion has focused on germline therapy, that is, artificially-designed alterations in the human genome that would not be limited to somatic tissues but would be passed on to succeeding generations. Currently, strategies for gene therapy that would result in alteration of the germline are not considered appropriate. Scientists and health professionals have become well-sensitized to the issues and arguments concerning germline therapy but, for the most part, have not participated openly in the debate on its potential benefits and harms. Based on existing technologies in human reproduction and on expected advancements in gene therapy technology, we believe that the debate on germline gene therapy must now also become the purview of scientists and health professionals. We have in fact already advanced beyond the theoretical considerations that have fuelled debate on germline gene therapy and must now begin to examine the issues based on clinical experiences. Indeed, for the popular press, prenatal genetic diagnosis, including preimplantation diagnosis via embryo selection (e.g. Handyside and Delahanty, 1993), is considered a form of germline gene therapy, and 'there (has been) not a murmur of dissent' (Lyon and Gorner, 1995).