Recent Developments in the Regulation of Heritable Human Genome Editing.

In 2018, the Chinese scientist He Jiankui presented his research at the Second International Summit on Human Genome Editing in Hong Kong. While it was intended that he facilitate a workshop, he was instead called on to present his research in heritable human genome editing, where he made the announcement that he had taken great strides in advancement of his research, to the extent that he had gene-edited human embryos and that this had resulted in the live births of two children. While his research ethic and methodology was interrogated, he insisted that two children, twin girls, had been born healthy and that there was another pregnancy (at the time) where birth of a third gene edited child would be imminent. This announcement generated a ripple effect in the scientific community and exposed the gaps in regulation and absence of law relating to the technology. This resulted in a flurry of activity and conversation around regulation of the technology, which scientists stated was not ready for human trials. This article reviews the Third Summit which was held in London in March 2023 and comments on the latest developments in the regulation of heritable human genome editing.

The CRISPR Patent Ruling and Implications for Medicine.

This Viewpoint discusses the CRISPR patent ruling, an ongoing patent dispute, and the implications for research and medical innovation.

Distinguishing grounds between gene editing and neoeugenic conduct: bioethical and legalconsiderations / Fundamentos de distinción entre edición genética y conducta neoeugenica: consideraciones bioéticas y legales

The present work has the objective of analyzing whether the practice of gene editing, from the teleological foundation, can generate a scenario of neoeugenic choices. This study analyzes the current stage of gene editing, together with the panorama of neoeugenic practices, to delimit the distinctive aspects between these concepts, based on the desired purpose in the practice of gene editing. For that, the analytical-discursive method was used, identifying fundamental connections related to the problem and interpreting the concepts presented in search of an adequate response to the objectives raised. The research was based on scientific articles published in specialized journals, as well as books and chapters in collective works. (AU)

El presente trabajo tiene como objetivo analizar si la práctica de la edición genética, desde el fundamento teleológico, puede generar un escenario de elecciones neoeugenésicas. Este estudio analiza la etapa actual de la edición de genes, junto con el panorama de las prácticas neoeugenésicas, con el fin de delimitar los aspectos distintivos entre estos conceptos, en función de la finalidad deseada en la práctica de la edición de genes. Para ello se utilizó el método analítico-discursivo, identificando conexiones fundamentales relacionadas con el problema e interpretando los conceptos presentados en busca de una respuesta adecuada a los objetivos planteados. La investigación se basó en artículos científicos publicados en revistasespecializadas, así como en libros y capítulos de obras colectivas. (AU)

Governing Heritable Human Genome Editing: A Textual History and a Proposal for the Future.

Heritable human genome editing (HHGE) has become a topic of intense public interest, especially since 2015. In the early 1980s, a related topic-human genetic engineering-was the subject of sustained public discussion. There was particular concern about germline genetic intervention. During the 1980s debate, an advisory committee to the Director of the National Institutes of Health (NIH)-the Recombinant DNA Advisory Committee (RAC)-agreed to provide initial public review of proposals for deliberate introduction of DNA into human beings. In 1984 and 1985, the RAC developed guidelines for research involving DNA transfer into patients. The committee also commented on the possibility of deliberately altering the human germline. We track the textual changes over time in the RAC's response to the possibility of germline genetic intervention in humans. In 2019, the NIH RAC was abolished. New techniques for genome editing, including CRISPR-based techniques, make both somatic and germline alterations much more feasible. These novel capabilities have again raised questions about oversight. We propose the creation of a new structure for the public oversight of proposals to perform HHGE. In parallel with a technical review by a regulatory agency, such proposals should also be publicly evaluated by a presidentially appointed Bioethics Advisory Commission.

Ethics and regulatory considerations for the clinical translation of somatic cell human epigenetic editing.

Altering the human epigenome with gene-editing technology in attempt to treat a variety of diseases and conditions seems scientifically feasible. We explore some of the ethical and regulatory issues related to the clinical translation of human epigenetic editing arguing that such approaches should be considered akin to somatic therapies.

What we know about effective public engagement on CRISPR and beyond.

Advances in gene editing technologies for human, plant, and animal applications have led to calls from bench and social scientists, as well as a wide variety of societal stakeholders, for broad public engagement in the decision-making about these new technologies. Unfortunately, there is limited understanding among the groups calling for public engagement on CRISPR and other emerging technologies about 1) the goals of this engagement, 2) the modes of engagement and what we know from systematic social scientific evaluations about their effectiveness, and 3) how to connect the products of these engagement exercises to societal decision or policy making. Addressing all three areas, we systematize common goals, principles, and modalities of public engagement. We evaluate empirically the likely successes of various modalities. Finally, we outline three pathways forward that deserve close attention from the scientific community as we navigate the world of Life 2.0.

CRISPR/Cas systems: opportunities and challenges for crop breeding.

Increasing crop production to meet the demands of a growing population depends largely on crop improvement through new plant-breeding techniques (NPBT) such as genome editing. CRISPR/Cas systems are NPBTs that enable efficient target-specific gene editing in crops, which is supposed to accelerate crop breeding in a way that is different from genetically modified (GM) technology. Herein, we review the applications of CRISPR/Cas systems in crop breeding focusing on crop domestication, heterosis, haploid induction, and synthetic biology, and summarize the screening methods of CRISPR/Cas-induced mutations in crops. We highlight the importance of molecular characterization of CRISPR/Cas-edited crops, and pay special attentions to emerging highly specific genome-editing tools such as base editors and prime editors. We also discuss future improvements of CRISPR/Cas systems for crop improvement.

Fruit crops in the era of genome editing: closing the regulatory gap.

The conventional breeding of fruits and fruit trees has led to the improvement of consumer-driven traits such as fruit size, yield, nutritional properties, aroma and taste, as well as the introduction of agronomic properties such as disease resistance. However, even with the assistance of modern molecular approaches such as marker-assisted selection, the improvement of fruit varieties by conventional breeding takes considerable time and effort. The advent of genetic engineering led to the rapid development of new varieties by allowing the direct introduction of genes into elite lines. In this review article, we discuss three such case studies: the Arctic® apple, the Pinkglow pineapple and the SunUp/Rainbow papaya. We consider these events in the light of global regulations for the commercialization of genetically modified organisms (GMOs), focusing on the differences between product-related systems (the USA/Canada comparative safety assessment) and process-related systems (the EU "precautionary principle" model). More recently, genome editing has provided an efficient way to introduce precise mutations in plants, including fruits and fruit trees, replicating conventional breeding outcomes without the extensive backcrossing and selection typically necessary to introgress new traits. Some jurisdictions have reacted by amending the regulations governing GMOs to provide exemptions for crops that would be indistinguishable from conventional varieties based on product comparison. This has revealed the deficiencies of current process-related regulatory frameworks, particularly in the EU, which now stands against the rest of the world as a unique example of inflexible and dogmatic governance based on political expediency and activism rather than rigorous scientific evidence.

The implications of the gender-based prohibitions relating to human germline genome editing in the Human Fertilisation and Embryology Act.

RESEARCH QUESTION: What are the implications of the gender-based prohibitions relating to human germline genome editing (hGGE) in the Human Fertilisation and Embryology (HFE) Act 1990, as amended in 2008? DESIGN: A three-phase primary research design consisting of a mixed-methods online public survey of 521 UK citizens aged 16-82 years, 13 semi-structured interviews with experts and professionals involved in the future of hGGE, and structured interviews with 21 people affected by genetic conditions. The research was conducted between March 2018 and October 2019. RESULTS: Gender-based prohibitions in the HFE Act weaken its intent to prevent germline cells that have been altered from resulting in a pregnancy and the possible birth of people with edited genomes. This weakness could become increasingly problematic as genome editing technologies develop and social advances seek to eradicate gendered expectations and gendered binaries. CONCLUSION: The HFE Act should be amended to avoid gender-based discrimination and the potential gender-based prohibitions have to circumvent germline genome editing being used before the technology is considered safe enough to prevent disease.

Legal and practical challenges to authorization of gene edited plants in the EU.

According to a predominant interpretation of the C-528/16 judgment of the Court of Justice of the European Union, mutants resulting from gene editing, even those featuring only single nucleotide variants, should be subject to the authorization procedures designed for organisms developed through genetic modification (i.e. insertion of large DNA fragments). In this article, we illustrate practical problems with the authorization of products of gene editing in the EU. On the basis of these problems, we analyze the influence of the current interpretation of EU legislation and judgment on the practical ability to authorize and detect such products on the EU market. We show that the predominant interpretation of the judgment leads to legally unacceptable consequences, in particular to the violation of the principle of proportionality with regard to individuals who wish to develop and market products of gene editing. As a result of our considerations, we show that the C-528/16 judgment did not need to be interpreted in the dominant way.