Ethical and Legal Aspects of Using Genome Editing Technologies in Medicine (Review)

Abstract

According to many experts, the turning point in the development of genome editing technologies (GET) was 2012, when Feng Zhang and Jennifer Doudna independently proposed the adaptive bacterial immunity system CRISPR/Cas9 for editing the genome of living cells of eukaryotic organisms. Since then, the range of applications of CRISPR/Cas9 technology and related GET has continued to grow like an avalanche. Thus, new genetically modified microorganisms, plants, and animals have been created, the experimental studies on the genetic foundations of life have greatly expanded, and revolutionary approaches to therapy and prevention of incurable diseases have been developed. However, the indisputable advantages of GET are associated with high risks (real and potential) to the environment, human health, and society as a whole. Significant progress in the genome editing in eukaryotes has led to a rapid appearance of humans with an "improved" genome, despite the openly expressed opposition of leading scientists working in this field. Among them, David Baltimore, Paul Berg, Jennifer Doudna, George Church, and Martin Jinek are calling for a global suspension of work with human embryos until the technical, legal and ethical standards in this area are developed. There is an urgent need for the development of an unambiguous public position and improvement of the regulatory framework for the GET, including that in the Russian Federation; the present review attempts to address the urgent issue of GET-related regulations. We discuss various approaches to regulating the use of GET in medicine. We review legal acts and ethical recommendations around the world concerning the GET-mediated modification of the plant and animal genetic material for the purpose of creating medical products and drugs. We also address the sensitive issue of editing the genome of human cells (somatic or germ). Special attention is paid to the relevant legal and ethical standards exiting in the Russian Federation. The presented data allow for a better understanding of the current situation and the areas of further research into GET, where the development and implementation of regulatory standards are especially urgent.

What do people think about genetic engineering? A systematic review of questionnaire surveys before and after the introduction of CRISPR

“…This is transversal from the early studies before the 1990s to the most recent studies, with little variation among the public and regardless of their origin. This is in agreement with international and national policies ( Walters, 1991 ; Horst, 2007 ; DH-Bio, Committee on Bioethics, 2015 ; Polcz and Lewis, 2016 ; Nicol et al, 2017 ), and indeed, several clinical trials of somatic gene therapy are underway ( EASAC, 2017 ; Karagyaur et al, 2019 ). Key challenges in the use of these therapies in the clinic raised by scholars regard their definition and regulation ( Nicol et al, 2017 ; Sherkow et al, 2018 ) and were partly recognized in some of the public opinion surveys, including the “need for strict regulation” in somatic therapy (Eurobarometer, 2010) and the need for FDA approval to proceed ( STAT and Harvard, 2016 ).…”

Three decades of gene therapy development: milestones and prospects

“…Отдельного внимания заслуживает использование вирусных векторов для доставки компонентов систем редактирования генома, однако данная область является еще крайне дискутабельной с позиции трансляционных перспектив. Рассуждать о ее развитии и промежуточных итогах представляется более целесообразным после достижения глобального консенсуса в этических и правовых аспектах данного направления (13].…”