Legal Regulation of Biotechnologies: World Experience in the Development of Biological Law and Bioethics

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In this article, the author turns her attention on the most pressing issues in the area of biomedicine and biotechnology legal regulation in a row of countries of the European Union, the USA and Russia. The author puts the emphasis on development of the new branch of law "bioethics". Also, unique models  and proposals to put forward for the implementation of the most suitable world models in the medical and legal area to the same domain in Russia are considered.

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作者简介

Sofia Purtova

编辑信件的主要联系方式.
Email: sonapurtova1@gmail.com

independent researcher

俄罗斯联邦, Moscow

参考

  1. Convention on the Protection of Human Rights and Human Dignity in connection with the Application of the Achievements of Biology and Medicine (ETS No. 164) // "ConsultantPlus".
  2. Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine, Oviedo, 4.IV.1997 // URL: https://rm.coe.int/168007cf98.
  3. Universal Declaration on the Human Genome and Human Rights (Adopted on 11.11.1997 at the 29th session of the UNESCO General Conference)// "ConsultantPlus".
  4. International Declaration on Human Genetic Data (Adopted by resolution UNESCO General Conference on the report of Commission III at the 20th plenary meeting on October 16, 2003 // URL: https://www.un.org/ru/documents/decl_conv/declarations/genome_dec.shtml.
  5. Universal Declaration on Bioethics and Human Rights (Adopted by resolution UNESCO General Conference on the report of Commission III at the 18th plenary meeting on October 19, 2005) // URL:https://www.un.org/ru/documents/decl_conv/declarations/bioethics_and_hr.shtml.
  6. General Data Protection Regulation / GDPR — Regulation No. 2016/679 of the European Parliament and of the Council of the European Union "On the protection of individuals in the processing of personal data and on the free circulation of such data, as well as on the repeal of Directive 95/46/EC (General Regulation on the Protection of Personal Data)" // URL: https://gdpr-text.com/ru.
  7. Directive 2004/23/EC on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells; Regulation (EC) No 1394/2007 on Advanced Therapy Medicinal Products.
  8. Directive 2001/20/EC on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of Good Clinical Practice in the conduct of clinical trials on medicinal products for human use.
  9. Regulation (EU) No 536/2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC.
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  13. Loi du 2 août 2021 relative à la bioéthique // a été publiée au Journal officiel du 3 août 2021 // URL: https://www.vie-publique.fr/loi/268659-loi-2-aout-2021-bioethique-pma.
  14. Valdés, Erick, au: Lecaros, Juan 2019/01/01 (978-3-030-05902-6). Biolaw and Policy in the Twenty-First Century Building Answers for New Questions: Building Answers for New Questions.
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