THE USE OF STEM CELLS IN THERAPEUTIC TREATMENT PROCEDURES: LEGAL AND ETHICAL ASPECTS

The use of stem cells in therapeutic treatment procedures involves both legal and ethical aspects. The law and medical ethics walk hand-in-hand in this regard. The tremendous progress and advances in biomedical research, as well as developments in new treatment procedures, are contributing to more and more successes in the healing process. A consequence of these new biomedical techniques and treatments is that the law, and especially legislative requirements, cannot keep up with such techniques and treatments. At this stage there is no legislation in force in South Africa to regulate the use of stem cells in the therapeutic treatment of patients. The South African Parliament promulgated the National Health Act 61 of 2003 a few years ago, but, as at the time of writing, the sections dealing with stem cells are still not in force. These sections permit the therapeutic cloning of human stem cells and,if it eventually comes into force, it will allow the therapeutic cloning of human stem cells for use to the benefit of patients, and will also assist practitioners. The legal and ethical aspects regarding the usage of stem cells in the therapeutic treatment of patients and not for research on stem cells, form the basis of this article. The discussion will include aspects such as stem cells and where they are derived from, patients’ rights to choose to make use of stem-cell therapy, informed consent for stem cell treatment, the recognition of novel treatment procedures, the practitioner’s scope of practice as well as legislative control to indicate the need for such control.

Therapeutic cloning: promises and issues

Advances in biotechnology necessitate both an understanding of scientific principles and ethical implications to be clinically applicable in medicine. In this regard, therapeutic cloning offers significant potential in regenerative medicine by circumventing immunorejection, and in the cure of genetic disorders when used in conjunction with gene therapy. Therapeutic cloning in the context of cell replacement therapy holds a huge potential for de novo organogenesis and the permanent treatment of Parkinson's disease, Duchenne muscular dystrophy, and diabetes mellitus as shown by in vivo studies. Scientific roadblocks impeding advancement in therapeutic cloning are tumorigenicity, epigenetic reprogramming, mitochondrial heteroplasmy, interspecies pathogen transfer, low oocyte availability. Therapeutic cloning is also often tied to ethical considerations concerning the source, destruction and moral status of IVF embryos based on the argument of potential. Legislative and funding issues are also addressed. Future considerations would include a distinction between therapeutic and reproductive cloning in legislative formulations.

Human Dignity as a Normative Principle

Böckenförde was one of the most outspoken critics of attempts to legalize new biomedical techniques, such as human cloning, therapeutic cloning, and pre-implantation genetic diagnosis. In this article, he lays out why the legal principle of human dignity, enshrined in Article 1 of the German Basic Law, not only suggests but even requires the prohibition of such techniques. Drawing on the records of the 1949 Parlamentarischer Rat (the constitution-drafting body), he is able to show that with Article 1 the drafters sought to set a counterpoint to fascist Germany’s total negation of human dignity and that the preservation of human dignity was intended to be the highest and most pressing aim of the Federal Republic. Böckenförde notes further that the Federal Constitutional Court adopted the Kantian view that human dignity means every human being is an end in itself. But who is ‘every human being’? Does it include unborn life? Böckenförde answers in the affirmative and argues that the unborn therefore must be protected by the state from the very beginning of life, from the point of fertilization. Every other point in time in human development, such as the implantation of the embryo in the uterus, or the development of the central nervous system, would be arbitrary criteria for eligibility as a bearer of human dignity. Therefore, all biomedical techniques which treat the embryo not as an end in itself must be prohibited. He lays out the consequences of this argument in detail with regard to cloning and pre-implantation genetic diagnosis.

THE RIGHT TO CLONE: SOME ASPECTS OF THE CONTEMPORARY DISCOURSE

The aim: The paper aims to analyze some aspects of the contemporary discourse which concern the determination of the content and specificity of the right to clone. It also outlines the main trends in the development of legal regulation of cloning within international and national law and order. Materials and methods: Methodologically, this work is based on the system of methods, scientific approaches, techniques and principles with the help of which the realization of the research aim is carried out. There have been applied universal, general scientific and special legal methods. Conclusions: Regarding the findings of the study it is necessary to note the following. First, if there is a shared negative vision of the feasibility of reproductive cloning in general, which is enshrined in international and national legislation, the need for therapeutic cloning remains an unresolved issue. Secondly, medicine advances and accordingly sees new perspectives and innovative developments in the field of therapeutic activity, in particular, related to the results of therapeutic cloning, which can help in the fight against incurable diseases. Hence, there is the necessity of further research aimed at the improvement of the existing mechanisms for implementing therapeutic cloning, and determining its limits and procedural aspects.

ԹԵՐԱՊԵՎՏԻԿ (ԲՈՒԺԱԿԱՆ) ԿԼՈՆԱՎՈՐՄԱՆ ԿԻՐԱՌՄԱՆ ԻՐԱՎԱԿԱՆ ՀԻՄՆԱԽՆԴԻՐՆԵՐԸ ՀԱՅԱՍՏԱՆԻ ՀԱՆՐԱՊԵՏՈՒԹՅՈՒՆՈՒՄ/THE PROBLEMATIC LEGAL ISSUES OF THERAPEUTIC (MEDICAL) CLONING IN THE REPUBLIC OF ARMENIA/ОБ ОСНОВНЫХ ПРАВОВЫХ ПРОБЛЕМАХ ПРИМЕНЕНИЯ ТЕРАПЕВТИЧЕСКОГО (МЕДИЦИНСКОГО) КЛОНИРОВАНИЯ В РЕСПУБЛИКЕ АРМЕНИЯ

The article is focusing on the problematic legal issues of therapeutic (medical) cloning. The paper analyzes the definition, types, purpose of the cloning, prospects for the use of therapeutic cloning; the paper also highlights the problems in this field and proposes suggestions to clarify them. Based on the analysis, it also provides conclusions regarding the legislative amendments and addendums related to the clarification and improvement of the cloning institute. The paper refers to the incomplete legal regulation of this institute, in particular the absence of special low of the Republic of Armenia on legal regulation of the cloning, the necessity to study the prospects for the regulation of international legislation on the prohibition of reproductive cloning and the development of therapeutic cloning.

Tinjauan Etika terhadap Kloning Manusia

Etika ialah cabang filsafat yang mengkaji prinsip-prinsip moral yang mengatur perilaku seseorang, sehingga dapat juga disebut sebagai filsafat moral. Disiplin etika lebih bersifat normatif dan preskriptif daripada deskriptif atau eksplanatori. Kaidah-kaidah etika perlu dipergunakan dalam menentukan objek penelitian dan aplikasi pengetahuan, agar terhindar dari kemunculan dampak negatif dari riset sains dan penerapan pengetahuan sains di masyarakat, seperti kerusakan lingkungan dan dehumanisasi. Sejauh ini kasus isu moral terkait sains yang menjadi wacana publik salah satunya adalah kloning manusia. Terdapat dua jenis kloning yang sasaran utamanya manusia, yaitu kloning reproduksi (reproductive cloning) dan kloning terapeutik (therapeutic cloning). Kloning reproduktif bertujuan untuk menghasilkan individu baru, sedangkan pada kloning terapeutik, embrio manusia diklon bukan untuk tujuan reproduksi melainkan untuk pembuatan sel-sel punca (stem cells) untuk mengobati berbagai penyakit manusia. Sel-sel punca adalah sel-sel yang relatif belum terspesialisasi dan dapat mereproduksi diri secara tak terbatas, dan dalam kondisi yang sesuai berdiferensiasi menjadi sel-sel terspesialisasi menjadi satu tipe sel atau lebih. Keberhasilan teknik-teknik kloning manusia menimbulkan isu-isu etis yang menyulut debat panas. Berdasarkan paham teleologi dapat dinyatakan bahwa kloning reproduktif manusia tidak etis ditinjau dari akibat yang dapat ditimbulkan dari teknologi tersebut, seperti mengacaukan silsilah keturunan, rentan terhadap pelanggaran hak hidup yang layak, dan resiko kecacatan.