Will ART be the same as cloning?

1. Introduction

The cloning of Dolly the sheep in 1996 by a team of scientists led by Ian Wilmut and Keith Campbell from the Roslin Institute in Scotland was a great event in the world of science, about which one could hear and read in the vast majority of the media of the time^[1]. Scientists have proven that it is possible to clone a mammal from an adult cell, contrary to the current state of research, which showed that the cells of adult organisms can no longer perform embryonic functions. This event was not only a medical breakthrough, but also had ethical, cultural and social consequences^[2]. Cloning Dolly opened up new perspectives in medicine and animal husbandry, as the possibility of cloning could help treat genetic diseases, produce drugs, and protect endangered species. Some scientists and experts have also made plans about human cloning, or at least such experiments that – related to cloning – will have a positive impact on improving the quality of people's lives^[3]. However, the cloning of the sheep has sparked debate about the ethical and moral consequences of cloning, influencing legislation at the international and national levels^[4].

The purpose of these considerations is not to give an unambiguous answer to the question posed in the title, because – as it seems – the answer “yes” or “no” is not yet scientifically possible. However, the author intends, on the basis of an analysis of the reaction of the international and national legislator (Poland) to the cloning of Dolly the sheep, to indicate possible solutions in relation to the increasingly bold and at the same time effective and dangerous effects of assisted reproduction techniques, which will at least partially answer the question about the further fate of ART.

2.  Prohibition of human cloning in universal international law

There are several key acts in universal and regional international law that relate to human cloning, especially reproductive cloning.

Among the acts of international law of a universal nature, referring directly to the prohibition of human cloning, one should point to one of the first international documents introducing ethical restrictions in genetic engineering, i.e. the UNESCO Declaration on the Human Genome and Human Rights of 1997^[5]. Article 11 of the document states that “Practices contrary to human dignity, such as human cloning for reproductive purposes, should not be allowed”. Therefore, this article clearly states that human cloning for reproductive purposes is incompatible with human dignity and should be prohibited. However, the prohibition does not refer to therapeutic cloning, which left some room for interpretation and subsequent national regulation^[6]. It is also worth noting that the Declaration emphasizes that the human genome is the common heritage of humanity and should be protected from unethical manipulation. Article 3 states that every person has the right to respect for his or her dignity and rights in connection with genome research, while Article 10 of the Declaration states that scientific research in the field of the human genome must respect human rights and fundamental freedoms. UNESCO's 1997 declaration is not a legally binding treaty (it is merely a “declaration”), but it has formed the basis for many subsequent international and national regulations^[7].

The UNESCO Declaration contributed, among other things, to the adoption of the United Nations Declaration on Human Cloning of 8 March 2005, which went a step further by recommending a ban on all forms of human cloning^[8]. In the Declaration adopted by the UN General Assembly, it recommends a ban on all forms of human cloning because they are “incompatible with human dignity and the protection of life”. Thus, the protection of human dignity, human rights and human life in the context of biotechnological research is emphasized. The UN declaration calls for national laws to prohibit reproductive and possibly therapeutic cloning and for biomedical research to be conducted in an ethical and human-rights-compliant manner^[9].

The prohibition of human cloning can also be indirectly derived from a number of other acts of international law of a universal nature^[10]. A sufficient reason is the obligation to respect and protect human dignity and the prohibition of scientific or medical experiments without consent. By way of example, we can point to the International Covenant on Civil and Political Rights of 1966^[11]. Article 7 of this pact does not refer directly to cloning, but prohibits scientific experiments on humans without their consent.

3.  Prohibition of human cloning in international, regional and supranational law - Europe

In the system of human rights protection of the Council of Europe, one of the key roles, including in the use of modern reproductive technologies, is played by the Council of Europe Convention on Human Rights and Biomedicine, i.e. the so-called Oviedo Convention of 1997^[12]. Article 18 (2) "It shall be prohibited to create human embryos for research purposes". Although the European Union is not a party to this Convention, many Member States have ratified it^[13].

            Much more unambiguous wording is contained in the Additional Protocol to the Convention for the Protection of Human Rights and Dignity of the Human Being in the Context of Applications of Biology and Medicine, which was adopted on 12 January 1998. As follows from Article 1 of the Protocol “Prohibition of cloning of human beings”: “Any intervention aimed at creating a human being genetically identical to another human being, living or dead, is prohibited”. The prohibition is therefore unambiguous and covers all forms of cloning, regardless of the purpose. Article 2 states that States which ratify the Protocol undertake to enact appropriate provisions in national criminal law^[14].

Although the European Union is not a party to the Oviedo Convention or the Additional Protocol thereto, the prohibition of human cloning is formulated in European Union law^[15]. Article 3(2) of the Charter of Fundamental Rights of the European Union states: “In the fields of medicine and biology, the following must be respected: (a) the free and informed consent of the person concerned, in accordance with the procedures laid down by law, (b) the prohibition of eugenic practices, in particular those aimed at the selection of persons, (c) the prohibition of the use of the human body and its parts as a source of profit,  (d) the prohibition of reproductive cloning of human beings”. This provision is central to EU primary law when it comes to banning human cloning. It has been formulated directly, it does not require interpretation from other provisions, as in the case of other regional universal acts indicated in this study^[16].

In the Community/EU law, the title issue is also covered by Directive 98/44/EC of the European Parliament and of the Council of 6 July 1998 on the legal protection of biotechnological inventions^[17]. Article 6(2)(a) of the Directive states: “Inventions whose use would be contrary to public policy or morality, in particular those concerning: human cloning, modification of the human germline, use of human embryos for industrial or commercial purposes, shall not be patentable”^[18]. On the other hand, Directive 2004/23/EC of 31 March 2004 on quality and safety standards for donated human cells and tissues does not refer directly to cloning, but lays down strict rules on the use of human tissues and cells, which indirectly affects restrictions on cloning research^[19].

The legal prohibitions on human cloning under EU law have been confirmed by the Court of Justice of the European Union. By way of example, Oliver Brüstle v Greenpeace e.V. (C-34/10, 2011) can be cited. The Court found that inventions using human embryos for commercial or patent purposes are incompatible with EU values. In addition, it reaffirmed the ban on patenting inventions involving the cloning of human embryos^[20].

4.  Prohibition on human cloning in Polish law

The starting point for a brief analysis of the sources of Polish law concerning human cloning, both in the context of reproductive and therapeutic cloning, should be the Constitution of the Republic of Poland of 2 April 1997^[21]. It follows from Article 8 of the Constitution that it is the supreme law of the Republic of Poland, which means that all other legal acts and regulations should be consistent with it. Although there is no provision in the Polish Constitution that would directly refer to the title issue, the significance of Article 30 of the Constitution of the Republic of Poland can hardly be overestimated for the above reasons: “The innate and inalienable dignity of man is the source of freedom and rights of man and citizen. It is inviolable, and its respect and protection is the duty of public authorities”. The protection of human dignity is therefore the basis for the prohibition of cloning^[22].

At the subconstitutional level, the prohibition of human cloning was formulated directly in the Act of 1 July 2005 on the collection, storage and transplantation of cells, tissues and organs^[23]. Article 18 provides for an unambiguous prohibition: “It is forbidden to clone a human being in any form”^[24]. A similar prohibition was formulated in Article 15 of the Act of 25 June 2015 on infertility treatment^[25]: “paragraph 1 Human cloning is prohibited”. The next paragraph of this article also prohibits “the use of techniques leading to the creation of human beings with identical genomes for reproductive and therapeutic purposes”^[26]. The provisions of the two acts cited above are the most direct provisions prohibiting human cloning^[27] in Poland. Their importance is emphasized by Article 76 of the Act of 6 June 1997 Criminal Code: “Whoever performs human cloning is subject to imprisonment from 3 months to 5 years”. This provision contains the most important criminal sanction for human cloning^[28].

When considering the Polish regulations prohibiting human cloning, the Act of 5 December 1996 on the professions of doctor and dentist cannot be omitted^[29]. In Article 25(2): “It is prohibited to conduct medical experiments that may violate human dignity and human rights”. Although this provision does not explicitly prohibit cloning, it may nevertheless be interpreted as a ban on human cloning, as this would violate the dignity and rights of the individual, which are referred to not only in this article, but also in genere in the above-mentioned Article 30 of the Constitution of the Republic of Poland^[30].

5.  What is the future of ART?

The event, which was the cloning of Dolly the sheep in 1996, influenced international and national standards regarding the prohibition of human cloning. In international law, such prohibitions are formulated in documents of a dual nature (convention or declaration), which means that their legal effects are different, i.e. prohibiting or recommending, and thus often leaving a lot of room for interpretation, as in the case of the ban on reproductive cloning of humans, which does not explicitly exclude therapeutic cloning. In Polish law, on the other hand, the ban on cloning is unambiguous, and the provisions of "medical acts" are reinforced by sanctions provided for in the Penal Code and constitutional provisions indirectly relating to the subject matter^[31].

            In the context of the above considerations and observations on cloning, what future awaits assisted reproductive technologies? Will they be banned?

The World Health Organization (WHO) has been monitoring and comparing the availability and regulation of ART in different countries for years. In its reports, it indicates different approaches to ART, which leads to a distinction between liberal and prohibitive models. In the case of the Council of Europe, documents related to the Convention on Human Rights and Biomedicine (the so-called Oviedo Convention, 1997) identify different approaches to ART in the Member States. On the other hand, the International Federation of Gynaecological and Obstetric Societies (FIGO) issues ethical guidelines and legal analyses for the use of ART, identifying regulatory models based on practices in different countries^[32].

Despite common international legal bases of a universal and regional nature, the legal provisions concerning ART differ from one country to another. To put it simply, national laws determined by historical, cultural, social, religious, and other factors vary greatly around the world. Most often, there are three or four main models of ART, which determine the availability, admissibility and scope of procedures.

The liberal model is based on legal provisions that provide wide access to ART, with minimal restrictions on eligible groups, methods of use and protection of embryos. The legal regulations in the countries applying this model (Australia, Belgium, Spain, Canada, the Netherlands, the United States) are relatively diverse in terms of availability and techniques^[33].

The moderately restrictive model – which includes, on the one hand, the legal systems of countries such as France, Germany, Italy, Switzerland (moderately restrictive model) and on the other hand, more restrictive ones of countries such as Ireland, Costa Rica, Malta, Poland (restrictive model) – is based on a balance between access to ART and the protection of ethical, religious and social values. Laws in these countries focus on restricting access to ART only to selected groups (e.g., heterosexual couples), and on protecting embryos and prohibiting the commercialization of procedures. This model seeks to reconcile innovative medical technologies with traditional values^[34].

The model prohibiting assisted reproductive technologies is the most restrictive legal approach, in which ART procedures are completely banned or practically unavailable. Legal systems that prohibit ART are influenced by religious or cultural factors and the prioritisation of the protection of life from conception. In countries applying this model, not only is the right to ART restricted, but its use is often penalized^[35]. Examples of such countries are Algeria, Saudi Arabia, Iran, Honduras, Nicaragua, Vatican City.

In conclusion, with such a diverse approach to the use of assisted reproductive technologies in the world, it is difficult to develop a single model, let alone a ban on the use of ART.^[36] At least at this stage of the development of human rights protection standards.

^[1] Cloning Dolly the sheep is one of the most important developments in the field of biotechnology and genetics. Dolly was the first mammal to be cloned from the somatic cell of an adult individual, which means that it was created by the transfer of the cell nucleus (SCNT – Somatic Cell Nuclear Transfer).

^[2] S. Franklin, Dolly Mixtures: The Remaking of Genealogy, Duke University Press, March, 2007

^[3] I. Wilmout, K. Cambell, C. Tudge, Dolly's Re-Act of Creation and the Era of Biology Control, Rebis: Poznań, 2002. 

^[4] J.E. Kapelańska, Klonowanie człowieka i embrionalne komórki macierzyste w świetle prawa międzynarodowego i porównawczego, Wydawnictwo Adam Marszałek, Toruń 2006.

^[5] The declaration was adopted by the UNESCO General Conference on 11 November 1997 and subsequently approved by the UN General Assembly in 1998 as a reference document on the ethical aspects of human genome research. Universal Declaration on the Human Genome and Human Rights – UNESCO, https://libr.sejm.gov.pl/tek01/txt/inne/1997.html.

^[6] P. Zieliński, Deklaracje bioetyczne UNESCO jako źródło uniwersalnych standardów bioetycznych, Lublin 2022.

^[7] A. Bałaban, E. Michałkiewcz-Kądziela, Prawne aspekty klonowania człowieka, „Teka Komisji Prawniczej PAN Oddział w Lublinie” 2019, 12 (1), pp. 15–29.

^[8] United Nations Declaration on Human Cloning. Adopted as a UN General Assembly Resolution nr A/RES/59/280 on 8 March 2005.

^[9] A. Bałaban, E. Michałkeiwcz-Kądziela, Prawne aspekty klonowania człowieka, „Teka Komisji Prawniczej PAN Oddział w Lublinie”, 2019, 12 (1), pp. 15–29.

^[10] K. Cynk, Prawa człowieka a reprodukcyjne klonowanie istot ludzkich, https://repozytorium.ur.edu.pl/server/api/core/bitstreams/7b4a4d3c-ef3c-4557-bdfd-70c9c855de92/content [accessed: 4.03.2025]

^[11] International Covenant on Civil and Political Rights opened for signature in New York on 19 December 1966. 1977 No. 38 item 167.

^[12] J. Skrzypczak, Europejska konwencja bioetyczna wobec wyzwań współczesności, „Medyczna Wokanda” No. 13 2009, pp. 29-38.

^[13] The Additional Protocol to the 1998 Convention against the Cloning of Human Beings is compatible with EU law.

^[14] D. E. Cutas, Looking for the Meaning of Dignity in the Bioethics Convention and the Cloning Protocol, “Health Care Analysis” 2005, vol. 13, no. 4, p. 303–312.

^[15] Charter of Fundamental Rights of the European Union; Dz.U.UE.C.2007.303.1

^[16] C. Mik, Klonowanie człowieka w pracach Unii Europejskiej, „Medycyna Wieku Rozwojowego”, vol. 5, Art. No. 1 Suppl 1, 2001, [Online]. Available on: https://pubmed.ncbi.nlm.nih.gov/11684778/.

^[17] Directive 98/44/EC of the European Parliament and of the Council of 6 July 1998 on the legal protection of biotechnological inventions, Dz.U. L 213 z 30.7.1998, p. 13–21

^[18] A. Bałaban, E. Michałkeiwcz-Kądziela, Prawne aspekty klonowania człowieka, „Teka Komisji Prawniczej PAN Oddział w Lublinie” 2019, 12 (1), pp. 15–29.

^[19] Directive 2004/23/EC of the European Parliament and of the Council of 31 March 2004 on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells, Dz.U. L 102 z 7.4.2004, p. 48–58.

^[20] Ethical consequences of the CJEU judgment in the case of Brustle C-34/10, https://ordoiuris.pl/ochrona-zycia/etyczne-konsekwencje-wyroku-ts-ue-w-sprawie-brustle-c-3410 [access – 04.03.2025 r.]

^[21] Constitution of the Republic of Poland of 2 April 1997, Dz. U. z 1997 r. Nr 78, poz. 483.

^[22] A. Bałaban, E. Michałkiewcz-Kądziela, Prawne aspekty klonowania człowieka, „Teka Komisji Prawniczej PAN Oddział w Lublinie” 2019, 12 (1), pp. 15–29

^[23] Act of 1 July 2005 on the collection, storage and transplantation of cells, tissues and organs, i.e. Journal of Laws of 2023, item 1185.

^[24] E. M. Guzik-Makaruk, Transplantacja organów, tkanek i komórek w ujęciu prawnym i kryminologicznym, „Temida” 2 Białystok.

^[25] The Act of 25 June 2015 on Infertility Treatment, i.e. Journal of Laws of 2020, item 442.

^[26] K. Nazar, Ustawa o leczeniu niepłodności, [in:] Pozakodeksowe przestępstwa przeciwko zdrowiu, ed. M. Mozgawa Warszawa: Wolters Kluwer, 2017, p. 197; E. Wojewoda, Prawnokarne i kryminologiczne aspekty medycznie wspomaganej prokreacji, Białystok „Temida” 2, 2019.

^[27] Act of 6 June 1997 – Penal Code, i.e. Dz.U. of 2024, items 17, 1228, 1907, 1965.

^[28] M. Gałązka, Klonowanie człowieka w świetle polskiego prawa karnego, „Prawo i Więź” No. 2 (49) 2024, pp. 264-292.

^[29] Act of 5 December 1996 on the professions of doctor and dentist, i.e. Dz.U. 2024, items 1287, 1897.

^[30] M. Kopeć, Ustawa o zawodach lekarza i lekarza dentysty. Komentarz, Warsaw 2016.

^[31] A. Bałaban, E. Michałkiewicz-Kądziela, Legal aspects of human cloning, „Teka Komisji Prawniczej PAN Oddział w Lublinie” 2019, 12 (1), pp. 15–29.

^[32] J.A. Robertson, Assisted Reproduction in Germany and the United States: An Essay in Comparative Law and Bioethics, „bepress Legal Series” 2004 paper 226.

^[33] J.A. Robertson, Assisted Reproduction in Germany and the United States: An Essay in Comparative Law and Bioethics, „bepress Legal Series” 2004 paper 226.

^[34] J. Kondratiewa-Bryzik, Początek prawnej ochrony życia ludzkiego w świetle standardów międzynarodowych, Warsaw 2009.

^[35] M. Ienca, O. Pollicino, L. Liguori, E. Stefanini, and R. Andorno, eds. The Cambridge Handbook of Information Technology, Life Sciences and Human Rights, Cambridge: Cambridge University Press, 2022.

^[36] L. Bosek, Refleksje wokół prawnych uwarunkowań prokreacji. The article comes from the debate held on 14.03–24.03.2009 entitled How to regulate in vitro fertilization?

References

Sources of law:

Deklaracja została przyjęta przez Konferencję Generalną UNESCO w dniu 11 listopada 1997 roku, a następnie zatwierdzona przez Zgromadzenie Ogólne ONZ w 1998 roku jako dokument referencyjny dotyczący etycznych aspektów badań nad genomem ludzkim. Universal Declaration on the Human Genome and Human Rights – UNESCO, https://libr.sejm.gov.pl/tek01/txt/inne/1997.html.

Dyrektywa 2004/23/WE Parlamentu Europejskiego i Rady z dnia 31 marca 2004 r. w sprawie ustalenia norm jakości i bezpiecznego oddawania, pobierania, testowania, przetwarzania, konserwowania, przechowywania i dystrybucji tkanek i komórek ludzkich, Dz.U. L 102 z 7.4.2004, p. 48–58.

Dyrektywa 98/44/WE Parlamentu Europejskiego i Rady z dnia 6 lipca 1998 r. w sprawie ochrony prawnej wynalazków biotechnologicznych, Dz.U. L 213 z 30.7.1998, p. 13–21

Etyczne konsekwencje wyroku TS UE w sprawie Brustle C-34/10, https://ordoiuris.pl/ochrona-zycia/etyczne-konsekwencje-wyroku-ts-ue-w-sprawie-brustle-c-3410 [dostęp – 04.03.2025 r.]

International Covenant on Civil and Political Rights opened for signature in New York on 19 December 1966. 1977 No. 38 item 167.

Karta praw podstawowych Unii Europejskiej, Dz.U.UE.C.2007.303.

Konstytucja Rzeczypospolitej Polskiej z dnia 2 kwietnia 1997 r., Dz. U. z 1997 r. Nr 78, poz. 483, z 2001 r. Nr 28, poz. 319, z 2006 r. Nr 200, poz. 1471, z 2009 r., Nr 114, poz. 946.

United Nations Declaration on Human Cloning. Przyjęta jako Rezolucja Zgromadzenia Ogólnego ONZ nr A/RES/59/280 dnia 8 marca 2005 roku.

Ustawa z dnia 1 lipca 2005 r. o pobieraniu, przechowywaniu i przeszczepianiu komórek, tkanek i narządów, t.j. Dz. U. z 2023 r. poz. 1185.

Ustawa z dnia 25 czerwca 2015 r. o leczeniu niepłodności, t.j. Dz. U. z 2020 r. poz. 442.

Ustawa z dnia 5 grudnia 1996 r. o zawodach lekarza i lekarza dentysty, t.j. Dz. U. z 2024 r. poz. 1287, 1897.

Ustawa z dnia 6 czerwca 1997 r. - Kodeks karny, t.j. Dz. U. z 2024 r. poz. 17, 1228, 1907, 1965.

Literature:

Bałaban, A. and Michałkiewicz-Kądziela, E. (2019) ‘Prawne aspekty klonowania człowieka’, Teka Komisji Prawniczej PAN Oddział w Lublinie, 12(1), pp. 15–29.

Bosek, L. (2009) ‘Refleksje wokół prawnych uwarunkowań prokreacji. Artykuł pochodzi z debaty przeprowadzonej w dniach 14.03–24.03.2009 pt. Jak uregulować zapłodnienie in vitro?’

Cutas, D.E. (2005) ‘Looking for the Meaning of Dignity in the Bioethics Convention and the Cloning Protocol’, Health Care Analysis, 13(4), pp. 303–312.

Cynk, K. (n.d.) ‘Prawa człowieka a reprodukcyjne klonowanie istot ludzkich’. Available at: https://repozytorium.ur.edu.pl/server/api/core/bitstreams/7b4a4d3c-ef3c-4557-bdfd-70c9c855de92/content (Accessed: 4 March 2025).

Franklin, S. (2007) Dolly Mixtures: The Remaking of Genealogy, Duke University Press.

Gałązka, M. (2024) ‘Klonowanie człowieka w świetle polskiego prawa karnego’, Prawo i Więź, 2(49), pp. 264–292.

Guzik-Makaruk, E.M. (n.d.) Transplantacja organów, tkanek i komórek w ujęciu prawnym i kryminologicznym, Temida 2: Białystok.

Ienca, M., Pollicino, O., Liguori, L., Stefanini, E. and Andorno, R. (eds.) (2022) The Cambridge Handbook of Information Technology, Life Sciences and Human Rights. Cambridge: Cambridge University Press.

Kapelańska, J.E. (2006) Klonowanie człowieka i embrionalne komórki macierzyste w świetle prawa międzynarodowego i porównawczego, Wydawnictwo Adam Marszałek: Toruń.

Kondratiewa-Bryzik, J. (2009) Początek prawnej ochrony życia ludzkiego w świetle standardów międzynarodowych, Warszawa.

Kopeć, M. (2016) Ustawa o zawodach lekarza i lekarza dentysty. Komentarz, Warszawa.

Mik, C. (2001) ‘Klonowanie człowieka w pracach Unii Europejskiej’, Medycyna Wieku Rozwojowego, 5(1), Art. nr 1 Suppl 1. Available at: https://pubmed.ncbi.nlm.nih.gov/11684778/ (Accessed: 4 March 2025).

Nazar, K. (2017) ‘Ustawa o leczeniu niepłodności’, in Mozgawa, M. (ed.) Pozakodeksowe przestępstwa przeciwko zdrowiu. Warszawa: Wolters Kluwer.

Robertson, J.A. (2004) ‘Assisted Reproduction in Germany and the United States: An Essay in Comparative Law and Bioethics’, bepress Legal Series, paper 226.

Skrzypczak, J. (2009) ‘Europejska konwencja bioetyczna wobec wyzwań współczesności’, Medyczna Wokanda, 13, pp. 29–38.

Wilmout, I., Cambell, K. and Tudge, C. (2002) Ponowny Akt Stworzenia Dolly i era panowania nad biologią, Rebis: Poznań.

Wojewoda, E. (2019) ‘Prawnokarne i kryminologiczne aspekty medycznie wspomaganej prokreacji’, Temida 2: Białystok.

Zieliński, P. (2022) Deklaracje bioetyczne UNESCO jako źródło uniwersalnych standardów bioetycznych, Lublin.