Legal

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This Blog is written by Palak Sinha from Symbiosis Law School, Noida. Edited by Anshika Porwal.

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INTRODUCTION

The new age of biotechnology begins to own its complimenting impacts, in fields of human interests, by applying modern technologies on modern societies. This has an excellent prospect, to alter the current biotechnology, influence it, or completely change human life exists on earth. The various dimensional application of these genetic technologies in fields of gene selection, sex opting, cloning, gene therapy, or even gene manipulation has completely changed and influenced the way of living of humans. But, the same can also result in discrimination and disparities within societies, all over the world as well.

Genes are the biological functional units of cells, of all living organisms. The human genome has been decoded further since the past decade, and this has begun to influence our biology and technology in elementary. There’s a birth of many difficult ethical issues, as a result of these Genetic Technologies such as in fields of genome, robotics, nanotechnology, synthetic biology and neuro-technology. These issues are expected to become the core foundation of the legal and lethal forces of the government and will also, help non-governmental organizations in the future.

The study of genomes that is basically the totality of all information of genes of an organism has acquired enormous importance in the present day and a more important field is Genetic Engineering, also known as Genetic manipulation or Genetic modification. India is a signatory of the Cartagena Protocol on Biosafety. However, it is yet to be included in the national regulations of the country. However, the biggest question of debate here is the future of these new technologies and the procedure of dealing with it.

The traditional plant breeding process is a time-consuming process, they are more certainly unable to cope with the changing environment, climate and water supply. Thus, the Gene modification or alteration technologies are relatively fast processes, they facilitate easy replication and mass production of the crops and plants. No one can deny the risks caused by these advanced technologies but, amidst this technological revolution, scientists have found their way, to empower the plants with the desired traits as per the location. [1]

SIGNIFICANCE ON DEVELOPMENT

The research and studies on the Genes or the genome data have anticipated that the decoding of the human genome and by gaining detailed knowledge about them, there’s a possibility for new advances and avenues in biotechnology and the world of medicine. The UNESCO International Bioethics Committee had its committee established, to draft the regulations and guidelines on the human genome.[2] It is an international declaration on human genetics, its meetings reflect the basis of obtaining this international support and the time analysis of when they worked independently.

Genetic tests and technology is slowly emerging as an essential component in the biotechnology and healthcare sector. They are establishing as the means, to find the treatment to the difficult diagnoses and detect the persons, who are vulnerable to risks before even actually suffering from the disease. By using the genome-editing or altering process technology, the need is to correctly mutate the human embryos, so that they can possess the genes from their parents. [2]

Within a very short span of time, the Genome Editing Technology has increased its potential application areas, in a wide range of sectors. The increasing research and experiments in this field have been successful, in understanding the basis of biology, under the strict oversight monitoring and ethical training in some countries. The basic pair modification of genes is combining it with a foreign gene insertion. As a consequence, the product of this modification/alteration may have many undetectable traits, when compared to its parent mutant. These traits are usually dependent on the nature-identical mutant gene. So, this current nucleus used for gene experiments are not completely error-free but, it may achieve some off-target goals in the meanwhile as well.

APPLICATION AREAS OF GENETICS TECHNOLOGIES

The main categories of application of the Genetic Technologies are Human Cloning, the process of creation of genetically identical human children or embryos from their dead or living parents. The Genetic Trait Selection, which refers to the special selection of sperm, embryos, eggs that embrace the genes of, which they are related or associated with. Whereas the alter, manipulation, or change of the genes in body cells of a living human is known as Genetic Modification. [3]

The world has a special consensus over this Genetic Technological advancement. The issues of these applications have gained their places in the headlines of many newspapers and magazines, from the past few decades now. The identifying, sequencing of these genes influences the vast amount of gene data that has been in circulation as the ‘genomics revolution’. This offer to promise, the improving development in living organisms and human health.

The techniques like  Genome Editing Technology  has increased the productivity of the agricultural sector and advances its yielding. The results, to meet the constantly rising demand for food security and food availability, by constantly protecting the biotic traits of it. This diversity is also reflected in the government’s long term plans for advanced technology, toward protecting the scientific benefit of this knowledge.

The judicious use of advanced genome technology has variedly increased its application areas. Other application areas of the Genetic Technology are microbial technology, livestock breeding, improved crop, and plant protection, human and animal health care, bio-economy, and agricultural sector. The new and advanced Genetic Technology promises humankind, its security, and protection against the various infectious and non-infectious diseases.

 

IMPACT

The rapid growth and influential impact of Genetic Technologies, have made it of primary importance. Therefore, the leading leaders of the world have to pay their recognition, to the advanced development in this field. They further promote it, to face the standing challenges with new technologies, in the modern world in the areas of interests like law, policies, history, and ethics. This makes it an important oversight in both national and international degrees.

Although, some countries have already embraced the available, comprehensive policies of their government on the much-debated Genetic Technologies. But, most of them still remain undecided on this matter. The recent boom in technology has improved the accuracy of genetic analysis, trait testing, and modification, but eventually led to the reduced cost of these areas. The wide interests and diversity have minimized the privacy goals for these genetic data. The ways in which these genetic data are admitted and held have made it difficult, to develop a proper genetic privacy policy for an individual’s safety.

On one hand, the legality of these gene technology patents is at the debate, as to the isolation of certain genes just amounts to ‘discovery’ and not ‘invention’, so it can’t be patentable. But, other statements to this debate include the presence of a purified gene, which is ‘invention’ and not ‘discovery’. The Government of India has its compliance, with the rules and provisions of the International treaties and agreements like Cartagena Protocol. It also proposed the enactment of the National Biotechnology Regulatory Authority through the Biotechnology Regulatory Authority of India (BRAI) Bill, 2013. However, in the past few years, it has suffered great opposition from farmers and many NGO’s. [4]

STATUTORY PROVISIONS

In India, genetically modified organisms (GMO’s) come under the regulation of the Ministry of Environment, Forest and Climate Change and is notified under the rules of the. The patentability of genes is still a matter of debate in the country but, the Indian Patent Office that grants the patents has understood the different standards for patents of a nucleotide sequences. [5]

The Genome Technology have inferences to the International treaties and agreements, like the Cartagena Protocol on Biosafety to the Convention of Biological Diversity. The Gene Patents under Section 3(c) of the Patents Act, 1970 includes the patenting for the discovery of any substance, whether living or non-living in nature. As per Section 3(j) states that the plants and animals as a whole unit are not patentable.

Other such applicable laws are:  The Biological Diversity Act, 2002; Seed Act, 1966; Protection of Plant Varieties and Farmers Rights, 2001; Food Safety and Standards Act, 2006;  Disaster Management Act, 2005; The Unlawful Activities (Prevention) Act, 1967; Weapons of Mass Destruction and Their Delivery System Act, 2005.

CASE LAWS

Diamond v. Chakrabarty (1980) 447 U.S. 303

Facts: – The plaintiff, Chakrabarty was a microbiologist and he sought to patent a live micro-organism, which was manmade.

Issue: – This particular human-made, genetically engineered bacterium had the capability of breaking down components of crude oil. So, does this no natural possession makes it significant value research? Can a live man-made micro-organism bacterium be patented?

Rule: – The United States Code (U.S.C.), Section 101 mentioning Inventions that are patentable under Chapter 10 stating the patentability of inventions. The rules under the Plant Patent Act, 1930 and the Plant Protection Act, 1970.

Application: – The requirement of Article 27(1) of TRIPS agreement,  which states that the inventions always need to involve an inventive step. Which essentially means an additional fact or knowledge, to the previously known data. It is a pre-requisite if one needs legal protection of the investment that consumed a lot of time and effort.

Conclusion: – The U.S. Supreme Court held that there is a distinction between the existence of living organisms in nature and the isolated organisms in nature, probably because of human intervention. This isolation makes the information and data of the gene unique and available in a way, that is not natural in nature, thus it should be considered an improved product. It was held that any live, micro-organism whether man-made is a subject matter and hence, constitutes as a matter within the statute. [6]

Harjinder Kaur and Ors. v. State of Punjab (2012)

Facts: – The respondent had an illicit relationship with the petitioner. When the petitioner denied the physical relations with him and his friends, the respondent blackmailed him. The respondent also tried attempting rape on the petitioner. The petitioner complained to the Police Commissioner, Ludhiana but no action was taken in the response. Then, a direction was released that there was no proper investigation of the case was conducted. There were no blood grouping tests done, the DNA test of the respondent, and the child was ordered. It was alleged that one of the friends of the respondent was posted in the near police station as well.

Issue: – Relevance of DNA testing? Whether reporters are allowed to see the court hearing? Difference between DNA sampling and DNA profile?

Rule: – Article 20(3), Article 21 (Right to Life) of the Indian Constitution. Section 53(A), Section 182 of the Criminal Procedure Code (CPC), 1973. Section 112 of the Indian Evidence Act, 1872. Section 452, 354, 380, and 149 of the Indian Penal Code, 1860.

Application: – Article 21 of the Indian Constitution states the right to life for individuals, it has always considered DNA tests as a violation. Facilitation of DNA testing guaranteed by the CPC, to prove the case in favor of the accused or otherwise.

Conclusion: – The respondent didn’t deny being the biological father of the child of the petitioner. He neither denied having physical contact with the mother of the child, the petitioner. The results of DNA testing were with an accuracy of 99.99%, confirming the paternity relation with the child. Police relied on the DNA testing results for this case and hence, turned out successful. Within 30 days of order receipt, the child and the respondent were sent for this testing in a laboratory. The Court held that adequate time was given, to the respondents to file the reply, of the petition against him. The matching of the DNA profiles is an essential tool to link people with their criminal acts of injustice.  [7]

 

DIMENSIONS OF GENETIC PRIVACY

The concept of ‘privacy’ has evolved over a period of time. But, there’s a question as to who, we could trust our genetic information and how they will hold and use it, still remains in question as well. There is a continuous debate, on whether the international guidelines on genetic technologies are justified or not. The international approaches, to the shared genetics technology and biological heritage, are the sole reasons for the preserved common interests and protect humanity in the world.

Researchers have found that individuals are more comfortable in sharing their genetic data and information with physicians rather than researchers of any institution. There is a widely distorted ratio that varies, in the number of people who are concerned about their genetic data and its privacy. Informational privacy is particularly, a very important aspect of the dimensions of genetic privacy. The significant concepts of this dimension are security, anonymity, and confidentiality. [8]

There is a different definition of how individuals define ‘privacy’. The scholars believe that the law does not provide much privacy and according to the beliefs of the people as well. The most controversial debate of all is to keep the genetic data and information as another sort of health information. The most important information is about the DNA and its potential use and implications for family members. This genetic information is also used in criminal justice by the statutory provisions.

The DNA profiles have success rates in solving many criminal cases with the help of forensic experts. Besides genetic identification, the behavioral study of these genes is used in various stages of criminal justice. Nowadays, genetic information is a major part of admission into many educational institutions and even for employment. A lot of health information provides us, with oversight of the genetic health of the individual.

 

ANALYSIS

The debate on the ability to diagnose, the genetic diseases has only created more panic, anxiety, and frustration because of the lack of successful treatment for these diseases. It is true, that these researches cost a fortune, which made the researches unjustified as there is no treatment available for these. The conflict is also, over the effects of these technologies on the environment both nationally and internationally. India’s current legal framework regarding the Genetic Technologies and organisms is arguably extensive. There are regulatory committees at the different research stages of these advanced technological researches.

At present, there is no specialized or specific statute that deals with the Genetic Technology or the Genetically modified organisms. There is no guide or provisional rules regarding the liabilities of these or the misappropriate handling or use of these technologies in India. However, the country does have a legal mechanism for redressing the grievances of people or to provide remedies to the aggrieved ones.

The factors that are important, before the release of the GMO’s into the environment, need to be assessed completely. This may include the nature and features of the GMO, the modification of the organism, or the stability of the new genes into the organism. This should be accompanied by the knowledge of the known and the expected changes/modifications in that very organism. As this technology gets advanced, it has improved our understanding of genetics and now, more organizations and entities try to seek this genetic information. [9]

The basic studies in biotechnology are conducted on the genetic analysis. This includes data and valuable information on genes, their inheritance, and disorders. Moreover, the genetic testing techniques have become more accessible over the period of time and more feasible in reference to time consumed.

CONCLUSION

There is a divided set of opinions regarding Genetic Technologies and its applications. There are few pieces of evidence that claim that some governments agreed to prohibit inheritable genetic, human reproductive cloning, and genetic trait alteration or modifications. However, the countries do suggest and promote the idea of further in-depth research on this topic for its better future application. There’s no doubt that this advanced Genetic Technology, has made the buying and selling of genetic materials more simple and reachable than before. Individuals are now buying these genetic materials for their own reproductive reasons at a reasonable availability rate.

However, the research in the field of biotechnology is the most successful one because of these advancements in Genetic Technologies. The coming of IVF, genetic modifications, and selections are considered ideal for further research for progress and development. Hence, there is support from all the powerful countries, to the advancement of Genetic screening and Genetic therapy. The issue of the DNA gene patenting still remains a concept that haunts the legal framework of privacy in the country. But, there is no substitute for the gene technology because it is the sole tool that improves the composition of the genome in humans. However, it is a weakened resolution by the big forces of industries that have invested hugely in the micro-biotechnology.

The development of these Genetic Technologies has always been in conflict with humanity and consumer rights as per the constitution of the country. Moreover, the overall experience with this Genetic Modified organisms and crops is still limited, to the development of the risk assessment methods first, to attain the safety. The challenging traits of these organisms are still anticipated as problems in the development let alone patents as well.

REFRENCES

[1] https://onlinelibrary.wiley.com/doi/abs/10.1111/j.1467-8519.2007.00564.x

[2]  https://www.researchgate.net/publication/326501205_Regulation_of_emerging_gene_technologies

[3] http://dbtindia.gov.in/sites/default/files/Draft_Regulatory_Framework_Genome_Editing

[4] https://academic.oup.com/jlb/article/6/1/1/5489401

[5]  http://bch.cbd.int/protocol/

[6] https://supreme.justia.com/cases/federal/us/447/303/

[7]  https://indiankanoon.org/doc/82201464/

[8]https://academic.oup.com/jlb/article/6/1/1/5489401

[9] http://www.legalserviceindia.com/articles/genetic_eng.htm

(1) Ahuja, V. (n.d.). Regulation of emerging gene technologies in India.

(2) AM, A. (2009). Journal of Medical Ethics and History of Medicine.

(3) Department of Biotechnology, G. o. (n.d.). Genome Edited Organisms: Regulatory Framework and Risk Assessment.

(4) Diamond v. Chakrabarty (United States Supreme Court 1980).

(5) Gene Technology. (n.d.). Retrieved from csiro.au: https://www.csiro.au/en/Research/Farming-food/Innovation-and-technology-for-the-future/Gene-technology

(6) Magazine, L. (2015). Human Genome And Patent Law In India.

(7) Shankar, B. B. (n.d.). EVALUATING THE LAW ON REGULATION OF GENETICALLY MODIFIED CROPS IN INDIA. Jamia Law Journal.