It seems that Alta Charo is not alone in his reasoning. Similarly, recent calls for a regulatory path to HGGE make little or no mention of humanity, human dignity or the human species. In order to better understand the normative change taking place in this context, I first describe the vision of human rights and human dignity as implied by existing human rights legislation on germline transformation. I then compare it to the vision of human rights as developed in recent proposals to replace bans on genetic modification of offspring with regulatory systems. How should administrations respond to the birth of “CRISPR babies”? Interestingly, national and international legal systems have been waiting a long time for the arrival of this revolutionary technology. Since the late 1990s, when the first legal framework for regulating biomedical developments came into being, the use of HGGE technologies for reproductive purposes has been banned in many national and international jurisdictions. A recurring thought in these legal frameworks is that genetic modification of offspring leads or can lead to practices that are contrary to human rights and the principles that underpin them, such as dignity, justice and equality. However, now that HGGE is within human reach, a global debate has erupted over whether these human rights prohibitions still make sense in the CRISPR era. As I will explain below, the first cracks in the existing human rights legal framework are beginning to emerge.

In addition, in scientific, political and academic circles, there is a growing call to move from banning to regulating HGGE. According to these recent proposals, the ban on hereditary genome editing for therapeutic purposes can be lifted once the technology can be safely introduced into the clinic. In contrast, much of what is allowed in the US would be more strictly regulated in the UK, where research on human gametes and embryos is subject to review by the Human Fertilisation and Embryology Authority and a licence is required for each specific set of experiments. (See Chapter 5 for a discussion of the clinical use of germline editing.) In other countries such as Chile12, Germany (DRZE, 2016), Italy (Boggio, 2005), Lithuania13 and Slovakia14, research would not be legal in any regulatory system. With regard to the individual dimension of dignity, both human rights bodies seem to agree with the need for clinical safety. They also point out that new genetic technologies “are likely to provide unprecedented tools against the disease”.142 However, they fear that HGGE will lead to new forms of discrimination and have a negative impact on individuals` self-perception and sense of freedom that results from it. Unesco`s IBC, for example, is concerned that socio-economic inequalities take root at the genetic level143 and is concerned about “the significant impact on the lives of individuals who might be conceived as being at the request of someone else without their consent”.144 The ecology of this system is an ecology in which there are many legal or political issues, that affect whether biotechnology is encouraged or hindered in a given country. This ranges from issues such as intellectual property rights, which are reflected in the areas of patent policy, to international trade law, which will have a major impact on whether and under what conditions new products can easily cross borders or not. The regulatory framework will determine the speed at which biotechnology will develop, from the laboratory to the development to the commercialized product. A final important question that needs to be addressed is what existing prohibitive or restrictive legal approaches to germline modification mean for germline research. For example, although EU law prohibits clinical trials that compromise the genetic identity of the subject`s germline, the question remains which rules apply to preclinical or basic research in this area. According to the European Group on Ethics in Science and New Technologies (EGE), the European Commission`s advisory body on ethical issues, not only the clinical application of this technology would raise serious concerns, but also research activities in this area, “given the profound potential consequences of this research for humanity”.90 The EGE does not specify: how these concerns should be implemented legally or politically, and what this means for the different stages of research.

When canada looked at assisted human reproduction, it formed a royal commission on new reproductive technologies, which held hearings on the subject across the country. In the European Union (EU), genetically modified foods, or GMOs as they are commonly known there, are of particular concern. There is actually an EU directive that states that there must be some public access to information when a product may affect biodiversity or other environmental elements. Human genome editing is largely prohibited by laws or guidelines, even in countries that allow research on human embryonic stem cells [4]. Many countries have banned human genome editing. Thirty-nine countries were studied and classified as “legislation-based prohibition” (25 countries), “directive-based prohibition” (4), “ambiguous” (9) and “restrictive” (1). China, India, Ireland and Japan prohibit genome editing on the basis of less enforceable guidelines than laws and amendments are subject to [3]. In the United States, human genome editing is not prohibited, but a moratorium is imposed under the vigilance of the guidelines of the Food and Drug Administration (FDA) and the National Institutes of Health (NIH). All clinical trial proposals for germline changes are rejected by the NIH`s Recombinant DNA Advisory Committee (RAC). Clinical trials are regulated by the FDA [5].

In the UK, legislation on the medical use of mitochondrial replacement is likely to lead to legal approval of germline nuclear genome editing, which can be easily modified by genome editing technology [6]. Regulatory pathways for gene therapy in other jurisdictions are similar to those in the United States in important respects (see Appendix B), particularly with respect to the central importance of assessing risks and benefits before placing it on the market. For example, gene therapy in South Korea has a very similar pathway to that of the United States, except that it includes a conditional approval system that allows for use with less solid evidence. The United Kingdom, like the United States, has a rigorous pre-market risk and benefit assessment, but uses gamete or embryonic therapies for more intensive regulation (see Boxes 2-2). The European Union has additional levels of quality control for “advanced therapy medicines”, which would include certain gene therapy products, although off-label use is allowed as in the United States (George, 2011). Japan uses a system for gene therapy products similar to the U.S. product regulations, in which new products are prospectively sorted according to the expected degree of risk and regulated accordingly. Singapore has also adopted a risk-based approach, with criteria such as whether manipulation is significant or minimal; whether the intended use is homologous or non-homologous22 and is combined with a drug, device or other biologic.

These criteria are similar to those used by U.S. authorities to decide whether tissues should be subject to the rules of transplant medicine or to the rules for marketing cell therapy products (Charo, 2016b). Box 2-2 illustrates the differences between the United States and other regulatory systems by describing the example of the United Kingdom.