Australia was at the cutting edge in the development of Artificial Reproductive Technology in the 1960s and 1970s. Regulatory responses were piecemeal: only a small number of the six states and two territories enacted legislation. The regulatory response to reproductive cloning and embryonic stem cell research has been more uniform, with nationally consistent legislation in the form of the Prohibition of Human Cloning for Reproduction Act 2002 and the Research Involving Human Embryos Act 2002, together with the Gene Technology Act 2000. This regulatory regime creates a prohibitory environment for germline genome therapy in Australia and provides little scope for genome editing research involving human embryos, even under licence. This chapter discusses the Australian regulatory regime, with particular focus on this triad of legislative instruments. Although Australia has made a commitment to science and health, and recognition of the right to found a family, the special status of the embryo is a paramount consideration. This chapter concludes that, as in many other countries, Australia is at a crossroads, and Australians must decide, collectively, how far genome editing research involving human embryos should be allowed to progress.

In France, civil law provisions on research involving human subjects, on donation and use of human body parts, and on medically assisted reproduction – originally developed between 1988 and 1994 and generally referred to as loi de bioéthique (law on bioethics) – specify whether and under which statutory conditions activities potentially leading to human germline genome modification can be undertaken. International law, including European law, poses further conditions. This chapter explores legislative and regulatory constraints on this type of research in France, analyzing how they developed over time to reach their present state. We will show that, in France, it is prohibited to create a human embryo solely for research purposes; that, however, research activities on supernumerary embryos and human embryonic stem cells are possible upon authorization by the national agency on biomedicine; but that, nevertheless, alterations to the genome of an embryo under circumstances that allow the modifications to pass on to future generations (i.e. through a successful pregnancy) are strictly prohibited. A peculiar feature of French legislation in this domain is that the law on bioethics is regularly updated in light of new technological or scientific developments, and as a result of a national public consultation held at least every five years. In 2018 one such rounds of public consultation took place, and a report summarizing its outcome is now being considered as the basis for possible legislative reform – including in the domain of genetic engineering. While it is not possible to anticipate future legislative developments, the report signals some degree of openness in the French civil society regarding the use of genetic engineering and genome editing, at least in the context of research.

This chapter examines the regulatory framework governing the use of human embryos and gametes in treatment and research in the United Kingdom.This framework, overseen by the Human Fertilisation and Embryology Authority (HFEA), permits the use of germline genome modification in human embryos for specific research purposes, but it does not currently allow such modified embryos to be used in treatment.The chapter goes on to consider how germline genome modification may become a licensable treatment in the future, building on the recent experience of regulating research into mitochondrial donation and its clinical application in the United Kingdom.The legal and ethical challenges raised against the use of mitochondrial donation (and likely to be raised against the clinical use of germline genome modification) are also considered, including concerns arising out of EU legislation.

The use of genetic technologies for reproductive, farming, agricultural and scientific purposes has long been a matter of public concern in Switzerland. As a result of a series of legislative initiatives at the federal level, as well as of popular referenda, the country developed one of the most restrictive regulatory environments in Europe for research, potentially leading to human germline genome modification. In particular, any genetic manipulation of reproductive cells or embryos is strictly forbidden, regardless its intended purpose. This chapter will illustrate the way constitutional- and federal-level legislation, as well as international law and regulatory provisions rigidly constrain research activities that could potentially lead to genetic alterations in humans and their progeny. In such a restrictive context, it is highly unlikely that recent technical advances in genetic engineering and genome editing will be employed to produce germline genome modifications for either medical or purely scientific purposes. Furthermore, while the Swiss National Advisory Commission for Biomedical Ethics has recently expressed partial support for basic research possibly involving the genetic modification of human embryos, there are currently no indications that legislative initiatives will be undertaken to ease current regulations on such controversial matters.

Belgium regulates research on human embryos, including germline modification, mainly through the 2003 Law regarding Research on Embryos In Vitro and the 2007 Law regarding Medically Assisted Reproduction and the Disposition of Embryos and Gametes. It allows the creation of embryos for research when the research goal cannot be reached by research on supernumerary embryos. The lawmaker only recognizes a gradual difference between embryos created for reproduction and later used for research and embryos specifically created for research purposes. The general rule in research is that no research can be performed for eugenic goals, i.e., selection or improvement of non-pathological characteristics of the human species. Everything that is not prohibited by the law is allowed. The conclusion, supported by the parliamentary debate, is that germline genome editing is permitted for corrective purposes (meaning elimination or correction of genetic diseases), if approval of the local ethics committee and the Federal Commission on scientific research on embryos in vitro is obtained.