The Legal and Regulatory Context for Human Gene Editing

The potential use of human gene editing is stimulating discussions and responses in every country. The author will attempt to provide an overview of legal and regulatory initiatives around the globe. But he needs to note that people are talking not only about government when they talk about law, regulation, and biotechnology. They are really talking essentially about an ecosystem that is made up of government, the public, and private industry, which produces innovative products based on the basic science and applied research coming out of their universities. The ecology of this system is one in which there are many legal or policy issues that combine to affect whether biotechnology is promoted or hindered in any particular country. The regulatory framework is going to determine the speed at which biotechnology moves from laboratory to development to marketed product.