Volume 19, Issue 60 (4-2025)
MLJ 2025, 19(60): 159-175 |
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Abbasi M, Zamaneh Ghadim N, Hazeri S. Legislative "Requirements" and "Criteria" in the Field of Stem Cell Technology Based on European Union Legislation. MLJ 2025; 19 (60) :159-175
URL: http://ijmedicallaw.ir/article-1-1957-en.html
URL: http://ijmedicallaw.ir/article-1-1957-en.html
1- Medical Ethics and Law Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
2- Roshdiyeh Higher Education Institute, Tabriz, Iran.
3- Institute for Bioethics and Health Law, Tehran, Iran
2- Roshdiyeh Higher Education Institute, Tabriz, Iran.
3- Institute for Bioethics and Health Law, Tehran, Iran
Abstract:
Background and Aim: The development of new cell therapy technology, which has been the product of stem cell research since the early 1980s, despite creating new horizons for improving and enhancing the quality of human life, has raised various legal and ethical issues and challenges in the type of use, the scope of its applications, and the legitimacy of research on humans in general. Scientists divide stem cells into three categories based on their characteristics and properties: embryonic stem cells, adult stem cells, and cord blood stem cells.
Method: This article, using an analytical-comparative method and relying on legal principles, seeks to provide a suitable model for legislating stem cell technology, in which bioethical principles are considered as "requirements" and the approaches of the National Stem Cell Science and Technology Document as its "criteria".
Ethical Considerations: EU countries have adopted a different legislative approach to the use and research on these cells, considering the aspects of bioethics and legal principles, and some EU documents and guidelines also contain some regulations regarding the standardization of this field of biomedical technology.
Results: In a general classification, some EU countries prohibit the use and research, some have imposed restrictions, and a group of countries do not have explicit laws or have not moved towards the standardization of stem cells at all. Iran, as one of the advanced countries in the field of stem cell technology, faces a legislative vacuum in this field. However, the necessity of standardization should be parallel to the development of this technology.
Conclusion: The development and approval of a comprehensive, multidimensional, and localized law in the field of stem cell technology is an inevitable necessity; A law that, while utilizing successful international models such as European Union regulations, is faithful to the fundamental principles of bioethics, Iranian jurisprudential and cultural considerations, and the requirements of the National Stem Cell Science and Technology Document.
Please cite this article as:
Abbasi M, Zamaneh Ghadim N, Hazeri SH. Legislative "Requirements" and "Criteria" in the Field of Stem Cell Technology Based on European Union Legislation. Medical Law Journal. 2025; 19: e15.
Method: This article, using an analytical-comparative method and relying on legal principles, seeks to provide a suitable model for legislating stem cell technology, in which bioethical principles are considered as "requirements" and the approaches of the National Stem Cell Science and Technology Document as its "criteria".
Ethical Considerations: EU countries have adopted a different legislative approach to the use and research on these cells, considering the aspects of bioethics and legal principles, and some EU documents and guidelines also contain some regulations regarding the standardization of this field of biomedical technology.
Results: In a general classification, some EU countries prohibit the use and research, some have imposed restrictions, and a group of countries do not have explicit laws or have not moved towards the standardization of stem cells at all. Iran, as one of the advanced countries in the field of stem cell technology, faces a legislative vacuum in this field. However, the necessity of standardization should be parallel to the development of this technology.
Conclusion: The development and approval of a comprehensive, multidimensional, and localized law in the field of stem cell technology is an inevitable necessity; A law that, while utilizing successful international models such as European Union regulations, is faithful to the fundamental principles of bioethics, Iranian jurisprudential and cultural considerations, and the requirements of the National Stem Cell Science and Technology Document.
Please cite this article as:
Abbasi M, Zamaneh Ghadim N, Hazeri SH. Legislative "Requirements" and "Criteria" in the Field of Stem Cell Technology Based on European Union Legislation. Medical Law Journal. 2025; 19: e15.
Keywords: Stem Cells, Legislation, Bioethics, European Union, National Stem Cell Science and Technology Document
Type of Study: Original Article |
Received: 2025/03/5 | Accepted: 2025/04/4
Received: 2025/03/5 | Accepted: 2025/04/4
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