Regulatory framework for genetically modified organisms in the Kingdom of Eswatini.

The Kingdom of Eswatini is a Party to the Convention on Biological Diversity and to the Cartagena Protocol on Biosafety. As Party, Eswatini has domesticated these agreements by passing the Biosafety Act, of 2012 to provide for the safe handling, transfer, and use of living modified organisms (LMOs) in the country. The Act regulates living modified organisms to be used for confined field trials, commercial release, import, export, and transit, and for food, feed, and processing. Guidance is provided for prospective applicants before any application is made to the Competent Authority. This framework also provides for the regulation of emerging technologies such as synthetic biology and genome editing. The regulatory framework for living modified organisms aims to provide an enabling environment for the precautionary use of modern biotechnology and its products in the country in order to safeguard biological diversity and human health.

Genome editing in food and agriculture: from regulations to consumer perspectives.

Genome editing (GE) has emerged as a technology that could revolutionize food and agricultural production. While its advent has evoked enthusiasm for a more sustainable food system, there exists heterogeneity in regulations and public opinions regarding the technology. This review discusses evidence on the implications of government regulations on GE, and perceptions of genome-edited (GEd) food and related regulations. The review highlights consumers' positive attitude and preference for GEd foods when compared with genetically modified foods, despite the limited awareness and knowledge of GE technology. While policy changes might trigger debates, providing tailored benefits, information to consumers could further improve their attitude toward GE.

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.

Heritable human genome editing: correction, selection and treatment.

Heritable human genome editing (HHGE) to correct a nuclear gene sequence that would result in a serious genetic condition in a future child is presented as 'treatment' in various ethics and policy materials, and as morally preferable to the 'selection' practice of preimplantation genetic testing (PGT), which is subject to the disability critique. However, whether HHGE is 'treatment' for a future child, or another form of 'selection', or whether HHGE instead 'treats' prospective parents, are now central questions in the debate regarding its possible legalisation. This article argues that the idea of 'treatment' for a future child is largely a proxy for 'seriousness of purpose', intended to distinguish HHGE to avoid serious genetic conditions from less obviously justifiable uses; that HHGE is best understood, and morally justified, as a form of 'treatment' for prospective parents who strongly desire an unaffected genetically related child and who have no, or poor, options to achieve this; that HHGE would be morally permissible if consistent with that child's welfare; that legalisation is supportable with reference to the right to respect for private and family life under Article 8 of the European Convention on Human Rights; and that HHGE is morally distinguishable from PGT.

Regulatory and governance gaps for human genome editing in Mexico.

Mexico has the in-house technical and regulatory capacity to undertake human genome editing (HGE) governance. However, its regulatory framework must be reformed to be more targeted and govern the application of any emerging HGE technologies, leaving no room for unethical or unsafe practices for reproductive purposes.

China's regulatory change toward genome-edited crops.

China's newly issued genome-edited crop safety assessment guidelines do not entirely deviate from the existing genetically modified regulatory regimes. However, there is an urgent need to reform the genome-edited regulatory framework based on scientific values and a novel regulatory philosophy that balances diverse values to enhance public trust.

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.

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.