By Avishi Shukla
Introduction
In today’s fast-paced day and age of modernization, there is no denying the fact that technology is an essential aspect of all our lives. It is a predominant feature of almost every activity of the humankind, from homes to multinational corporates. Technology brings with it the emergence of new ideas and breakthroughs, along with alterations in many pre-existing ideas. It is natural that such radical changes break ground for legal interventions. Thus, law and technology now find themselves at an unavoidable and much needed intersection.
One important yet less spoken about breakthrough of technology and science is cloning. Cloning is the process of making an individual that is genetically identical to another. Human cloning, in accordance with today’s technology, commonly aligns with
‘Therapeutic cloning’- wherein the cloned embryos or stem cells are created through nuclear transfer. These cells sometimes facilitate the treatment of many disorders and transplantations.
‘Reproductive cloning’- wherein somatic cell nuclear transfer is used to make a genetically identical copy of the donor
Dolly the Sheep and Its Legal Implications
When talking about real life experiments, Dolly the sheep is a very prominent case of cloning. She was the first mammal to be cloned and was a female Finn Dorset sheep. The successful result of a clone was brought about by reproductive cloning of an adult sheep cell through the process of SCNT (somatic cell nuclear transfer). The experiment was carried out by Ian Wilmut, Keith Campbell and other colleagues of theirs at Roslin Institute, University of Edinburgh, Scotland.
There were a vast range of legal implications of this very cloning experiment. In 2009, three years after Dolly’s death due to a lung disease, Roslin Institute received a patent for the method of SCNT used by them for the cloning. However, they went ahead to file for patent on Dolly the sheep herself, as well as any other cattle, sheep, pigs and goats that are to be cloned in the future using SCNT. Hereon began the legal scrabble between the Roslin Institute and The US Authorities.
Thereafter, the US Patent and Trademark Office turned down this patent claim. The Institute went on to the Patent Trial and Appeal Board in the form of an appeal against the rejection. The Board agreed with the PTO’s decision and upheld it in February 2013, along with keeping in line with the case of Diamond v. Chakrabarty (1980), wherein it was stated that a subject matter could only be patent eligible if it had ‘markedly different characteristics from any found in nature.’ This was because subject matter that is not man-made is ineligible for patents, unless it is new and inventive. § 101 of Title 35 U.S.C. also backed the Board’s decision, which stated that living things are not patentable subject matter.
Ultimately, The Federal Circuit on May 8th 2014, rendered Dolly and any other cloned cattle, sheep, pigs and goats unpatentable due to it being identical to something that already occurs in nature.
This decision was also in line with the case of Association for Molecular Pathology v. Myriad Genetics (2013), wherein it was stated that mere isolation of DNA sequences does not make it patentable, as DNA segments are naturally occurring and continue to be a ‘product of nature’.
Legal Provisions for Cloning
Worldwide
There are different cloning laws worldwide. India along with countries like Singapore, Sweden, Japan and Israel have banned reproductive cloning but allow for therapeutic cloning. On the other hand, countries like Egypt, Canada, France and Germany have banned human cloning altogether. Despite provisions at the national level, cloning is a process popular almost worldwide and needs to be dealt with as world citizens. However, as there is no binding authority at the international level legally, it becomes quite tedious to regulate such issues.
The United Nations is quite a well-known regulatory international authority. It has introduced a considerable number of legal provisions regarding cloning. On 8th March 2005, after the Sixth Committee’s recommendation in its report, the United Nations General Assembly adopted the United Nations Declaration on Human Cloning, after various concerns raised regarding reproductive cloning. As per this Declaration, all the Member States of the UN were called on to ‘prohibit all forms of human cloning inasmuch as they are incompatible with human dignity and the protection of human life.’ The Declaration provided a clear framework regarding human cloning to all Member States, facilitating better regulation.
Article 11 of UNESCO’s Universal Declaration on Human Genome and Human Rights (1997) provides that practices which are ‘contrary to human dignity, such as reproductive cloning of human beings, shall not be permitted’.
World Health Organization also published its resolution on ‘Ethical, scientific and social implications of cloning in human health’ in 1998, prohibiting reproductive cloning.
It was indeed felt that these initiatives were an important step necessary to ensure that cloning remained ethical, if practiced under safety measures.
India
India does engage in reproductive cloning of animals. In March 2009, India’s National Dairy Research Institute cloned the world’s first buffalo calf, Samrupa. It went on to create another buffalo clone in 2023 named Ganga, who was met by the President Draupadi Murmu as well.
Although there are several countries that still haven’t legislated on cloning, the Government of India has officially banned reproductive cloning of human beings.
However, India was actually not in favor of the United Nations Declaration on Human Cloning as it was of the opinion that only reproductive human cloning should be banned. India was, in fact, inclined toward the practice of therapeutic cloning, under certain bioethical guidelines.
Therefore, as per the Indian Council of Medical Research’s Ethical Guidelines for Biomedical Research on Human Subject (2007), cloning with the intent of creating an identical individual is banned, however therapeutic cloning with the purpose of research is allowed, only under certain safety measures.
Implications of Cloning
After the popular case of cloning Dolly the sheep, the phenomenon of cloning continued to rise. It therefore became imperative to introduce cloning laws within countries. Although there continues to be a growing concern around the issue of cloning due to various reasons, it also does have its fair share of advantages.
Pros and cons of cloning include-
Advantages
Reproductive cloning can be used to achieve a genetically identical version of the donor in order to achieve homogeneity and similar genetic setup. It can also help couples who are sterile.
Therapeutic cloning has turned out to be quite beneficial for humans as it is used to create healthy tissues outside the donor’s body that then replaces his/her damaged tissues. It thus facilitates the treatment of many disorders.
Along with this, by studying and researching on the stem cells produced through cloning, the molecular causes of many diseases can also be understood.
Disadvantages
Frequent use of reproductive cloning for the purpose of a similar genetic setup in offspring can lead to a decrease in genetic diversification, excessive volume of which can lead to the risk of extinction.
The creation of identical copies of individuals can also lead to dissension in the areas of societal and religious values regarding identity, individual freedom and more.
As cloning involves the process of cell division, it could also possibly be the harbinger of many new genetic disorders.
There are also a number of similarities between stem cells and cancer cells that aren’t clearly understood and analyzed yet. Both are known to multiply very rapidly. Along with this, certain studies show that after 60 years of cell division, the stem cells can turn into mutations of cancer cells.
Therapeutic cloning in humans involves the destruction of human embryos for the creation of stem cells, which also comes out to be an ethical problem.
Probable Solutions
After discussing various aspects of cloning, it becomes evident that legalities regarding cloning are a prerequisite in today’s world. It is essential that all countries should have clearly specified and codified laws enforced regarding a total /partial ban on human cloning. Iran, for example, has no specific and codified laws on human cloning altogether. This can prove detrimental for the country in the future, especially with its rapid development in science and technology. It can lead to scientific and intellectual property rights abuse.
While there are many countries with a total ban on cloning, those allowing therapeutic cloning should also have an elaborate set of rules and guidelines released by the concerned Ministry to ensure the procedure of cloning being practiced does not get harmful and dangerous to mankind.
An active discussion and research into the theme of cloning needs to be carried out frequently by international organizations like the UN and its various committees.
There will always continue to persist a dichotomy of right and wrong. Embryo destruction may be an ethical issue but the stem cells created from its destruction aim to save lives of many humans with damaged tissues, cells or organs, through cell replacement or transplantations.
Therefore, law must always act as a balance between the various pros and cons of human cloning so that it becomes an asset for humanity rather than a liability, in the ages to come.
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