Abraham Iojrish ::: Biography

LEGAL ASPECTS OF GENETIC ENGINEERIN
G

1.
Being the base of biotechnology, genetic engineering is a set of methods and approaches developed to produce biological structures with programmed hereditary transferred traits that can never be produced using traditional selection methods. Genetic engineering opens new prospects for our knowledge of nature laws, for our advances in solving medical problems, for modernization of industry and agriculture, and for the successful resolution of ecological problems.
Many countries have long ago passed numerous laws and legislative documents to regulate activity in the field of genetic engineering.
Human cloning is the greatest problem of genetic engineering. Successful cloning of the sheep Dolly in Edinburgh, Scotland, by the group led by Ian Willmut turned into reality the great long-time dream of scientists to experimentally create a living organism from one cell. As designed by Nature, only one cell, the ovule or the egg, can be fertilized and then divided many times switching proper genes on and off to form various organs and systems of the human body. As for the other cells taken from the skin, liver, heart, or any other organ, they are specialized and can only work within their original function. The more complex the organism, the greater the specialization of its cells. However, here we come to a paradox: every cell contains a unique individual gene pool, and this gene pool is identical for all cells including the egg.
The scientists from Scotland succeeded in making all the genes from a specialized cell to work for the development of the sheep. This resulted in the greatest scientific success of Ian Willmut and his co-workers.
Some decades ago scientists succeeded in plant cloning. Transgenic plants are now widely produced, and transgenic animals are used in many research endeavours. A 'test-tube baby' is no surprise, and the procedure has been successfully introduced into clinical practice.

2.
Human cloning occupies a special position in the range of legally problematic medical Hi-Techs. This technology suggests a new method of human reproduction: any cell of the organism can be forced to divide producing a living copy, a 'bio-print' of the whole body. In theory, cloning can completely substitute the complex system of the human organism.
This is not the first time humanity evidences the necessity to carefully consider legal and ethic problems raised by new technologies.

This on-line version of the book "Biomediale. Contemporary Society and Genomic Culture" is not full. The unabridged edition can be purchased in printed form as anthology. Requests should be sent to: bulatov@ncca.koenig.ru (full information) or in written form: 236000, Russia, Kaliningrad, 18, Marx str., The National Publishing House “Yantarny Skaz”. Phone requests: Kaliningrad +7(0112)216251, Saint-Petersburg +7(812)3885881, Moscow +7(095)2867666. On-line bookshop (in Russian): http://www.yantskaz.ru. Full reference to this book: "Biomediale. Contemporary Society and Genomic Culture". Edited and curated by Dmitry Bulatov. The National Centre for Contemporary art (Kaliningrad branch, Russia), The National Publishing House “Yantarny Skaz”: Kaliningrad, 2004. ISBN 5-7406-0853-7

Human cloning can be also considered a means of both medical and social support for the infertile couples. Probably this could be considered positive by society, since it has already accepted, though with serious ethical restrictions, the new reproductive technology of test-tube fertilization and surrogate mothers.

3.
Current viewpoints concerning human cloning are contradictory. The majority of USA citizens are negative about Ian Willmut's cloning experiments. They say cloning is impossible for both moral and legal reasons and think cloning would result in problems rather than in progress. Two thirds think that the US government should control everything related to animal cloning. As for human cloning, the respondents were even more careful. Three quarters of the respondents decided that artificial human reproduction goes against God's will, while 29% even got ready to participate in demonstrations against laboratory-based production of human beings. Only 7% of US citizens were happy about the possibility of attaining longer life by creation of an artificial twin.
Meanwhile, the media started to make ominous allusions to the upcoming organization of 'human farms,' 'producing human organs,' 'stealing human cells to clone,' 'cloning of the dead to slow down human evolution,' etc. However, lawyers call for realistic prediction of the effects of cloning. Obviously, 'human organs farms' will never become legal. But on the other hand, cloned people, if produced, should have the same rights as ordinary people.
A serious legal problem of human cloning is paternity identification. Three individuals can participate in the cloning process: the donor of the somatic cell, the donor of the egg, and the surrogate mother. If the somatic cell is taken from a man, then he can be considered the father, but what if the somatic cell is taken from a woman? Property rights of the cloned people also create a problem. Therefore it has become evident that in the near future certain sections of civil law should be reconsidered. As for the cloning itself, it is classified as biotechnology, and this means possibility of patenting it and consequently falling into the area of intellectual property and respective laws.
Agitation from the great scientific advance in the field of reproductive technologies is being mixed with reliable worries about our future. We should quickly act to protect legal science and to prevent dangerous and irresponsible work. Fortunately, the demarcation line separating good and evil is evident here: we should accept reasonable experiments on animals and ban cloning of humans. The border between animals and human separates legal and promising scientific experiments from dangerous and anti-human manipulations. This line should be clear to all scientists and it should be respected; only then can we protect legal scientific effort and prevent dangerous consequences for human life and human dignity.

4.
Rapid development of genetic engineering in the 1980s made it essential to reconsider legal regulations existing in Russia to form a contemporary legislative base to regulate activity in biotechnology and genetic engineering. Earlier regulation of this activity in Russia was defined by the existing medical-epidemiological regulating documents and instructions. At the time of planning and administrative control, regulation is this area could be successful based only on administrative standards and documents. However, profound change in the Russian economical system at the beginning of the 1990s required a wider range of legal regulation methods; these methods needed support from the civil law in order to properly control activity in the field of genetic engineering.
It became necessary to create a Russian national legislative background to control the development of biotechnology and genetic engineering. Moreover, this background appeared essential to allow Russian biotechnology and its products to enter the international agricultural/industrial/pharmaceutical market. The work on the draft law on safety in genetic engineering started in 1990. For this purpose a special Working Group was created from the staff of the Institute for State and Law (Russian Academy of Sciences) and experts in certain branches of genetic engineering. The new law should aim to regulate social relations in genetic engineering and to provide a legal background to form and develop the state policy in this field. The Law should also provide legislative regulations for introducing transformed organisms into the environment and for the use of genetically engineered products in order to prevent uncontrolled application of the newly developed biotechnological procedures. It was suggested that the Law should control various aspects of genetic engineering-related activity: basic research, generation and mass production of recombinant organisms and/or their products, directed introduction of the genetically transformed organisms into natural ecosystems.
In June 1996 the Federal Law On Federal Regulation in the Area of Genetic Engineering was approved by the Russian Duma (lower parliament). This law contains 14 articles.

5.
Beside general statements and definition of the main terms related to genetic engineering (articles 1-3), the document indicates the aims (article 4), the directions and the principles (article 5) of Federal regulation in the area of genetic engineering. The Law defines four levels for the risk of potential hazardous effect of genetic engineering activity on human health. These levels correspond to the internationally-adopted risk levels for working with microorganisms, viruses, and toxic compounds. As stated by article 8 of the Law, genetic engineering work is allowed for those persons whose professional background and experience warrants regulations for safety of genetic engineering research work; any organization working in genetic engineering should have appropriate laboratories, equipment, and specially certified staff. As stated in article 9, genetic engineering activity and the measures to provide for its safety are financed by the Federal budget, special projects and research grants, and any other sources except those prohibited by the Russian State Law. The law states that the information concerning safety of genetic engineering activity should be open to the public. The products resulting from genetic engineering activity should be ecologically and medically safe, this being confirmed by special certificates and markings.
In June 2000, a new Russian Federal Law was approved to introduce additions and corrections into the text of the Federal Law On Federal Regulation in the Area of Genetic Engineering. The main terms used in the articles of the Law were clarified. The most important addition was the statement that the human cloning ban should not be applied to research in gene diagnostics and gene therapy.

6.
The Federal Law On Federal Regulation in the Area of Genetic Engineering bans any manipulation of a human. However, the technology of animal cloning to obtain genetically identical individuals was successfully worked out in Russia, and the possibility of cloning a human (that is, to produce a genetically identical human copy) became real long ago. The Special Interdisciplinary Working Group organized by the Russian government analyzed the experience of other countries and the opinion of the Russian experts. The 5-year moratorium for human cloning was suggested as a reasonable act. This decision was supported by the Russian Ministry of Science, the Russian Ministry of Health, other official organizations and the scientific community.

This on-line version of the book "Biomediale. Contemporary Society and Genomic Culture" is not full. The unabridged edition can be purchased in printed form as anthology. Requests should be sent to: bulatov@ncca.koenig.ru (full information) or in written form: 236000, Russia, Kaliningrad, 18, Marx str., The National Publishing House “Yantarny Skaz”. Phone requests: Kaliningrad +7(0112)216251, Saint-Petersburg +7(812)3885881, Moscow +7(095)2867666. On-line bookshop (in Russian): http://www.yantskaz.ru. Full reference to this book: "Biomediale. Contemporary Society and Genomic Culture". Edited and curated by Dmitry Bulatov. The National Centre for Contemporary art (Kaliningrad branch, Russia), The National Publishing House “Yantarny Skaz”: Kaliningrad, 2004. ISBN 5-7406-0853-7

The five-year moratorium on human cloning in Russia aims to prevent out-of-control cloning activity on Russian territory, including the activity of foreign researchers unable to work in their own countries because of the restrictive laws. It should also provide conditions essential for development of Russian science in the area of cloning technology for medical purposes (transplantation, gene therapy, etc.).




This is not the first time humanity evidences the necessity to carefully consider legal and ethic problems raised by new technologies.



Human cloning is the greatest problem of genetic engineering.
In the photo: Dr. Severino Antinori, a famous Italian embryologist.

7.
Russia is ready, in general and in principle, to sign the Convention on Biomedicine and Human Rights (The Council of Europe, Strasbourg, 1996). Joining the Convention would result in discussion of the possibility of signing the additional document called the Protocol on the Prohibition of Cloning Human Beings (Paris, 1998). A country acceded to the Convention may also accede to this Protocol. Acceding to this ban is not obligatory for a country that signed the Convention, since this should be decided on a national basis. The Russian scientific community preferred a five-year moratorium rather than the strict ban stated by the Protocol. A draft law for the five-year moratorium on human cloning was approved in July 2001, and the law in its final form was approved in 2002 (see above).
Though Russia has a right to make its own decision concerning regulation of the new technology of human cloning, Russia should clearly formulate its national position and inform the European Council about it before signing the Convention. However, it should be kept in mind that both the Federal Law On Federal Regulation in the Area of Genetic Engineering (1996) and the Federal Law to introduce additions and corrections into the text of the Federal Law On Federal Regulation in the Area of Genetic Engineering (2000) do not consider cells as part of the human organism. It remains essential to discuss the limits of legislative regulation in order to prevent negative consequences. The following points should be considered:
а) Human clones should have the same rights and the same responsibility as human beings. People will never get the right to keep human clones isolated and to use them for spare body parts.
b) A living human being should not be cloned without written consent. Any human automatically receives a right to control his own genetic code. Any human should have a right to decide about his cloning after death and to define conditions for this cloning. It seems reasonable to prohibit the cloning of children since they cannot be considered responsible enough to make this decision.
c) Human clones can be carried and born only by an adult woman acting on her own will, without any enforcement. The growing of a human fetus outside the woman's body, e.g. in a laboratory device should be prohibited.
d) Since the existing evidence suggests a genetic base for cruel and aggressive behavior, it seems reasonable to prohibit the cloning of killers and other dangerous criminals.
These problems are in general discussed and regulated by the Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine: The Convention on Human Rights and Biomedicine. The work on this important document started in 1990, and was approved on November 19, 1996 (Strasbourg). The convention was opened for signature in Oviedo on April 4, 1997.

This on-line version of the book "Biomediale. Contemporary Society and Genomic Culture" is not full. The unabridged edition can be purchased in printed form as anthology. Requests should be sent to: bulatov@ncca.koenig.ru (full information) or in written form: 236000, Russia, Kaliningrad, 18, Marx str., The National Publishing House “Yantarny Skaz”. Phone requests: Kaliningrad +7(0112)216251, Saint-Petersburg +7(812)3885881, Moscow +7(095)2867666. On-line bookshop (in Russian): http://www.yantskaz.ru. Full reference to this book: "Biomediale. Contemporary Society and Genomic Culture". Edited and curated by Dmitry Bulatov. The National Centre for Contemporary art (Kaliningrad branch, Russia), The National Publishing House “Yantarny Skaz”: Kaliningrad, 2004. ISBN 5-7406-0853-7

The Convention states that any form of discrimination against a person on grounds of his or her genetic heritage is prohibited. The necessity of wide-scale public discussions concerning the progress in biomedicine and related to bioethics is stressed. The fundamental questions raised by the developments of biology and medicine should be the subject of appropriate public discussion in the light, in particular, of relevant medical, social, economic, ethical and legal implications.
The convention entered into force on December 1, 1999 in Denmark, Greece, San Marino, Slovakia and Slovenia (the first five states to ratify it).

8.
The special Protocol worked out as an addition to the Convention develops the statements concerning genetic engineering, first of all, article 18 of the Convention which bans creation of human embryos for research purposes. The Protocol prohibits "Any intervention seeking to create a human being genetically identical to another human being (sharing with another the same nuclear gene set), whether living or dead."
No derogation from the provisions of this Protocol is allowed, however this does not mean a ban of the cloning technique in cell biology. Special comments to the Protocol present detailed arguments of its statement. Before the end of 2001, the Protocol had been signed by 29 countries, including Spain, Slovakia, Slovenia, Greece and Georgia, and ratified by eight, and more governments have indicated their intention to accede to the text.
The Convention on Biomedicine and Human Rights of the European Council and Universal Declaration on the Human Genome and Human Rights, which was unanimously adopted by UNESCO's General Conference in 1997 and endorsed by the General Assembly of the United Nations in 1998 show the necessity of nationally-based actions to prevent any practice not in accordance with human dignity including the area of cloning carried out in order to reproduce a human individual.
Acceding of Russia to the European Council's Convention and to its additional Protocol appears well-timed and politically important, especially if to take into account that this step is favored by the current situation in Russian society.

Translated from Russian by Ekaterina Gupalo.




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COLOPHON

CONTENTS:

I. LABORATORY: science and technology

Svetlana Borinskaya. Genomics and Biotechnology: Science at the Beginning of the Third Millennium.

Mikhail Gelfand. Computational Genomics: from the Wet Lab to Computer and Back.

Irina Grigorjan, Vsevolod Makeev. Biochips and Industrial Biology.

Valery Shumakov, Alexander Tonevitsky. Xenotransplantation as a Scientific and Ethic Problem.

Abraham Iojrish. Legal Aspects of Gene Engineering.

Pavel Tishchenko. Genomics: New Science in the New Cultural Situation.
II. FORUM: society and genomic culture

Eugene Thacker. Darwin's Waiting Room.

Critical Art Ensemble. The Promissory Rhetoric of Biotechnology in the Public Sphere.

SubRosa. Sex and Gender in the Biotech Century.

Ricardo Dominguez. Nano-Fest Destiny 3.0: Fragments from the Post-Biotech Era.

Birgit Richard. Clones and Doppelgangers. Multiplications and Reproductions of the Self in Film.

Sven Druehl. Chimaera Phylogeny: From Antiquity to the Present.
III. TOPOLOGY: from biopolitics to bioaesthetics

Boris Groys. Art in the Age of Biopolitics.

Stephen Wilson. Art and Science as Cultural Acts.

Melentie Pandilovski. On the Phenomenology of Consciousness, Technology, and Genetic Culture.

Roy Ascott. Interactive Art: Doorway to the Post-Biological Culture.
IV. INTERACTION CODE: artificial life

Mark Bedau. Artificial Life Illuminates Human Hyper-creativity.

Louis Bec. Artificial Life under Tension.

Alan Dorin. Virtual Animals in Virtual Environments.

Christa Sommerer, Laurent Mignonneau. The Application of Artificial Life to Interactive Computer Installations.
V. MODERN THEATRE: ars genetica

George Gessert. A History of Art Involving DNA.

Kathleen Rogers. The Imagination of Matter.

Brandon Ballengee. The Origins of Artificial Selection.

Marta de Menezes. The Laboratory as an Art Studio.

Adam Zaretsky. Workhorse Zoo Art and Bioethics Quiz.
VI. IMAGE TECHNOLOGY: ars chimaera

Joe Davis. Monsters, Maps, Signals and Codes.

David Kremers. The Delbruck Paradox. Version 3.0.

Eduardo Kac. GFP Bunny.

Dmitry Bulatov. Ars Chimaera.

Valery Podoroga. Rene Descartes and Ars Chimaera.
VII. METABOLA: tissue culture and art

Ionat Zurr. Complicating Notions of Life - Semi-Living Entities.

Oron Catts. Fragments of Designed Life - the Wet Palette of Tissue Engineering.
VIII. P.S.

Dmitry Prigov. Speaking of Unutterable.

Wet art gallery

Biographies

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Webliography

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