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Этические и правовые вопросы применения технологий редактирования генома в медицине (обзор)

Этические и правовые вопросы применения технологий редактирования генома в медицине (обзор)

М.Н. Карагяур, А.Ю. Ефименко, П.И. Макаревич, П.А. Васильев, Ж.А. Акопян, Е.В. Брызгалина, В.А. Ткачук
Ключевые слова: технологии редактирования генома; модификация генома эмбриона; технологии CRISPR/Cas9; законодательное регулирование ГМО; этические нормы в медицине.
2019, том 11, номер 3, стр. 117.

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Поворотной точкой в развитии технологий редактирования генома (ТРГ), по мнению многих экспертов, стал 2012 г., когда Фенг Джанг (Feng Zhang) и Дженнифер Дудна (Jennifer Doudna) независимо друг от друга предложили использовать систему адаптивного бактериального иммунитета CRISPR/Cas9 для редактирования генома живых клеток эукариотических организмов. С тех пор спектр областей применения технологии CRISPR/Cas9 и родственных ей ТРГ продолжает лавинообразно увеличиваться: с их помощью создаются генетически модифицированные микроорганизмы, растения и животные, значительно расширяются возможности экспериментальных методов изучения генетических основ жизни, разрабатываются революционные подходы к терапии и профилактике ранее неизлечимых заболеваний.

Неоспоримые преимущества ТРГ оказались неизбежно сопряжены с высокими реальными и потенциальными рисками для экологии, здоровья человека и общества в целом. Стремительный прогресс в области редактирования генома эукариотических организмов неожиданно быстро привел к появлению первых людей с «улучшенным» геномом, несмотря на открыто высказанную позицию ведущих ученых, работающих в этой области: Дэвида Балтимора (David Baltimore), Пола Берга (Paul Berg), Дженнифер Дудна (Jennifer Doudna), Джорджа Черча (George Church), Мартина Джинека (Martin Jinek), призывавших к глобальному приостановлению работ с человеческими эмбрионами вплоть до момента выработки технических, правовых и этических норм в этой области.

Это демонстрирует острую необходимость в формировании однозначной общественной позиции и совершенствовании нормативно-правовой базы применения ТРГ, в том числе и в Российской Федерации, что стало предпосылкой для подготовки данного обзора литературы.

Рассмотрены различные точки зрения на подходы к регулированию использования ТРГ в медицине. Проведен анализ действующих в различных странах мира законодательных актов и этических рекомендаций, регламентирующих применение ТРГ для модификации генетического материала растений и животных с целью создания медицинских изделий и лекарственных препаратов, а также редактирование генетического материала соматических и герминативных клеток человека. Особое внимание уделено состоянию соответствующих правовых и этических норм в Российской Федерации.

Представленные данные позволяют лучше понять сложившуюся ситуацию и обозначить области применения ТРГ, где особенно остро стоит вопрос разработки и внедрения регуляторных норм.

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