Genome editing and international regulatory challenges: Lessons from Mexico

Abstract

Summary While human genetic modification has long been the subject of bioethical attention, the advent of new ‘genome editing’ techniques such as the CRISPR/Cas system has provoked renewed interest in this area. The comparative efficiency and precision of these techniques greatly increases their value to research as well as the scope of possible applications. Genome editing, in combination with stem cell science, has the potential to produce a new generation of somatic gene therapies. It is perhaps, however, the fact that these techniques make reproductive germline genetic modification a real and practicable possibility that has sparked scientific and ethical attention. While a moratorium on genome editing research, such as that called for by some in the wake of the first reported use of CRISPR in human embryos, may not be an effective or justified solution to such concerns, questions remain as to how such technologies should be regulated. A significant issue is that the attention given to genome editing techniques and their therapeutic potential is likely to stimulate demand from patient groups, especially in the case of conditions for which there are currently no effective treatments – as has happened with stem cell therapies. This, together with the relative ease of application of genome editing techniques, creates the very real possibility that (as for stem cells) in the absence of adequate regulation or oversight, clinical treatments using genome editing, whether somatic or reproductive, may be offered ahead of sufficient testing of safety and efficacy. This is likely to be most problematic in countries where unlicensed therapies are already prevalent; Mexico, for example, is a known destination for stem cell ‘treatments’, at least some of which are offered without rigorous scientific validation. Moreover, the phenomenon of medical tourism means that this is not just a problem for these countries but one that requires global cooperation to achieve an effective transnational regulatory solution. In this paper we consider the ethical and regulatory challenges presented by genome editing technologies and the problem of ‘rogue’ therapies, using the Mexican context as a case study to illustrate the potential pitfalls and issues that will need to be addressed to achieve effective governance in this area. Drawing on lessons learned from other areas of science and other jurisdictions, we suggest some principles that may help to develop an appropriate framework for regulating this fast-moving area of science.