However, British and Dutch legislators, for example, came to a different conclusion. In the United Kingdom and the Netherlands, modifications of nuclear embryonic DNA are prohibited, while modifications of nuclear mitochondrial DNA are not prohibited. It appears that legislators in both EU countries (at the time, the UK was still an EU member state) interpreted EU legislation`s references to “genetic identity” to mean that only modifications to nuclear embryonic DNA are affected by the current bans, leaving member states free to authorise modifications of mitochondrial DNA.75 Despite the absence of a national legal ban, the Netherlands has not yet adopted this technology. is still actively defended. This is due to other legal provisions that hinder the use of HNGT.76 In contrast, clinical trials were given the green light by the HFEA in December 2016, which was hailed as a “landmark decision” by the journal Nature.77 A final important question to be answered is what existing prohibitive or restrictive legal approaches to germline editing mean for research. in this area. For example, although EU law prohibits clinical trials involving the germline genetic identity of the subject, it remains an open question 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 be a matter of serious concern, but also research activities in this area “given the potentially profound consequences of this research for humanity”.90 The EGE does not assert that: how these concerns should be translated into legislation or policy, and what this means for the different stages of research. CRISPR is legal in the United States. Many hospitals and biotech companies are currently conducting clinical trials with CRISPR.

These studies are regulated by the FDA. If the trials are successful, the FDA will grant these organizations approval to market the drug as a commercial product. The U.S. government supports CRISPR research through these regulated clinical trials. Companies like Intellia, Editas and CRISPR Therapeutics are advancing this technology. I suspect that in 2-3 years (2023-2024), a CRISPR-based drug will hit the market. This paper argues that while applications of CRISPR in psychiatry are not imminent, these applications are no longer improbable hypotheses. And when there might be applications in psychiatry in the near future, there are important legal and ethical considerations that require careful consideration. This article is divided into three parts.

Part I serves as an overview of CRISPR technologies, analyzes the surface of relevant science, places CRISPR systems in their historical context, and evaluates the existing regulatory framework. The second part focuses on CRISPR and its potential applications in psychiatry and identifies where the technology could be most directly applied. Part III examines the legal, ethical, and policy challenges posed by the use of CRISPR in a psychiatric context. Britta van Beers is Professor of Biolaw and Bioethics at VU University Amsterdam, Faculty of Law, Department of Legal Theory. Britta van Beers teaches and writes about the legal philosophical aspects of biomedical technology governance. She is particularly fascinated by the legal and philosophical issues raised by assisted reproductive technologies, such as false births and illegitimate claims of life, selective reproduction and reproductive tourism. In her recent work, she has focused on issues of personalized medicine and human gene editing. She has actively contributed to public debates on new technologies by writing essays and editorials and speaking as an expert for the Dutch Senate and House of Representatives.

His publications include Personalized Medicine, Individual Choice and the Common Good (co-edited with Sigrid Sterckx and Donna Dickenson, Cambridge University Press 2018), Symbolic Legislation and Developments in Biolaw (co-edited with Bart van Klink and Lonneke Poort, Springer 2016) and Humanity across International Law and Biolaw (co-edited with Wouter Werner and Luigi Corrias, Cambridge University Press 2014). FCAC`s early actions included requiring each research institution to establish a Biological Risk Review Committee (later renamed IBC) to review risks and certify the existence of appropriate safety measures. The JRC`s first main task was to develop guidelines for recombinant DNA research which, although not legally regulatory, have an enormous impact on practices aimed at preventing the accidental release or exposure of humans to genetically modified organisms and materials (Rainsbury, 2000). The NIH guidelines are a condition of NIH funding and apply to all recombinant DNA research conducted or sponsored by a public or private institution that receives NIH funding for such research (NIH, 2013a). Many other U.S. government agencies and private institutions require that their funded research be conducted in accordance with NIH guidelines (Corrigan-Curay, 2013). An international group called HUGO also provides a legal basis for gene therapy interventions, but it is unclear whether this group has global authority. Accordingly, human dignity is explained in this approach as a legal principle that protects not only individual rights and freedoms (referred to in the academic literature as “the individual dimension of human dignity” or “dignity as empowerment”), but also the collective interests of humanity on which human rights are based (“collective dimension of human dignity” or “dignity as coercion”).141 Concerns about both dimensions of human dignity are evident in the Council. the European and UNESCO approach to human germline treatment. As of 2019, there is NO consistent, legally binding or universally accepted set of rules in the international arena of gene therapy or genome editing. 122.Mary Gearing, Treatment of muscular dystrophy with CRISPR gene editing, ADDGENE BLOG (January 26, 2016, 10:30), blog.addgene.org/treating-muscular-dystrophy-with-crispr-gene-editing [perma.cc/688P-NB5U]. Once the FDA approves a drug, it may be prescribed for uses different from those for which it has been approved and labeled.

As mentioned earlier, such off-label prescribing is a legal and common practice of health care providers if they deem it medically appropriate. This may mean using the product for a different medical condition than the one for which it has been approved (for example, approved for one type of cancer and used for another), or administering it at different doses, in different forms or to different categories of patients. Off-label prescribing allows doctors to use the information at their discretion after a drug has been initially authorized, while maintaining post-marketing surveillance for safety reasons. In the United States, certain areas of medicine, such as pediatrics (AAP, 2014) and cancer treatment (American Cancer Society, 2015), are known to have a high rate of off-label use. What does all this mean for HGGE governance? For Nuffield Council, the conclusion is that the medical frontier is too problematic to act as a red line to alter the human germline.132 The advisory committee proposes a new legal and ethical standard: genetic intervention should be in the best interests of the future child. As the Nuffield Council explains, this means that “there is no a priori reason why preferences beyond disease prevention should not also be compatible with the well-being of the future person.” 133 Liu LJ. Three legal problems of gene editing babies. www.jcrb.com/FYFZ/zxbd/201901/t20190114_1952628.html. Retrieved 3 March 2020. However, media reports in 2019 suggest that the UK was probably not even the first EU member state to approve clinical trials in this area.78 Also in 2016, Greek health authorities authorized clinical trials with HNGT.