GENETIC DISCRIMINATION AND PROTECTION OF GENETIC DATA
Updated: Mar 27
Author: Aakaanksha Akella, IV Year of B.A.,LL.B(Hons), from NMIMS Kirit P. Mehta School of Law.
The growth of Biotechnology, or more specifically Genomics as a science, has resulted in the much needed development of Bioinformatics as an interdisciplinary subject that analyses and interprets biological data. Ever since Watson and Crick discovered the structure of DNA in 1953, Genomics has impacted many fields of life, and its applications are said to be game-changing for healthcare and medicine.
In 1990, the Human Genome Project was launched whose goal was the ‘complete mapping and understanding of all the genes of human beings’ and under this project, an enormous amount of genetic data was gathered. Genome sequencing also helps in revelation and analysis of population-level predisposition to diseases, especially in countries such as India wherein, as a consequence of the prolonged practice of endogamous marriages, many genetic diseases have evolved.
Therefore, collection of genetic information could have far-reaching effects and transform healthcare in India. The increasing utilisation of genetic information and its far-reaching consequences have raised many concerns, especially privacy and misuse. It has been argued that DNA sampling of an individual could be intruding into four forms of privacy – bodily privacy, genetic privacy, behavioural privacy as well as familial privacy. In areas of employment, the employer is more likely to use genetic data not just for determining occupational diseases but also for healthcare cost-cutting purposes, and such usage of genetic data may be construed as contrary to the principle of purpose limitation as applicable to data protection.
It goes without saying that the use of genetic information and leveraging bioinformatics to cater to ‘personalised medicine’ is a potentially great initiative and ethical use of genetic information in the healthcare sector is not being contested, but one of the major issues arising out of this field is the use of genetic information for non-medical purposes without proper regulation.
The International Declaration on Human Genetic Data was adopted in 2003 to encourage international action through its guidelines. The Declaration in its Article 7 addresses genetic discrimination and calls for non-discriminatory use of genetic data which doesn’t infringe upon basic human rights, fundamental freedoms and individual dignity. To an extent, this Declaration manages to acknowledge concerns regarding the misuse of genetic data and touch upon aspects of consent, privacy and confidentiality, but at the end of the day, it is an instrument that cannot enforce and guarantee proper implementation of the guidelines. Apart from this, some countries have introduced legislations to combat genetic discrimination.
In the United States of America, there are mainly two legislations which address the problem of misuse of genetic data – the Genetic Information Non-Discrimination Act (GINA) and the Health Insurance Portability and Accountability Act (HIPAA). The latter was enacted in 1996 mainly as an insurance statute and has a Privacy Rule which ‘establishes national standards to protect individuals' medical records and other personal health information and applies to health plans, health care clearinghouses, and those health care providers that conduct certain health care transactions electronically.’ The GINA legislation, on the other hand, is more extensive and specific legislation dealing with genetic discrimination.
The statute mainly deals with genetic discrimination in (a) health insurance and (b) the workplace. The definition of genetic information under the Act covers information from the individual’s genetic tests, their family’s genetic tests as well as any manifest disease in family members.
The health insurance protections under GINA have wide application. However, these protections do not extend to the U.S. Military which is permitted to use genetic information of an individual for employment decisions, and these provisions also do not extend to life insurance, disability insurance and long – term care insurance. However, some states have legislated laws to make up for the lack of protection of such insurances under this Act. Additionally, GINA has no application for employers who have less than fifteen employees. Critics also argue that the piece of legislation hasn’t taken the much required leap to enable personal control over genetic testing results. The Act is also criticised on the grounds that it ends up in economic and healthcare inequities and fails in the larger picture of distributive justice by arguing that genetic information is more privileged compared to other medical records.
In India, the Council of Scientific and Industrial Research (CSIR) has financed the IndiGen Genome Project, which aims to undertake genome sequencing of individuals representing diverse ethnic groups from the country and create a pilot dataset to enable genetic epidemiology of carrier genetic diseases towards enabling affordable carrier screening approaches. The project has sequenced around 1,008 genomes already and plans to sequence 10,000 genomes by the next three years.
While this development is a great one, one cannot help but wonder about the flip side of the coin, especially due to the lack of regulations. The Indian Council of Medical Research does not have any specific guidelines to govern genetic testing laboratories. Genome data should specifically be considered sensitive when it comes to privacy concerns simply because such data does not only reveal information about the individual but also their immediate family as well as distant biological relatives.
Legally speaking, there have been some cases which have been brought in front of the judiciary regarding genetic discrimination by insurance companies. In the case of United India Insurance Company Limited v. Jai Parkash Tayal, the Delhi High Court held that ‘that right to avail health insurance is an integral part of the Right to Healthcare and the Right to Health, as recognised in Art. 21 of the Constitution, therefore discrimination in health insurance against individuals based on their genetic character, in the absence of appropriate genetic testing and the laying down of intelligible differentia is unconstitutional.’ However, the Supreme Court has stayed this order, and there have been no further developments in this case.
Fact remains that genetic discrimination is being practiced on the ground, and the government has not done enough yet to combat it.
Data privacy in general is only recently being considered a topic of importance in India, with legislations still in the making to ensure citizens’ right to privacy. The landmark Puttaswamy judgement of 2017 which held the right to privacy as a fundamental right is our first source of understanding the position of rights with respect to genetic data. The initial draft of the Personal Data Protection Bill, 2019 was based heavily on the GDPR. This piece of redrafted legislation which now almost gives the government a free pass is in need of thorough analysis on this particular aspect, otherwise it has no real use in prevention of breach of data privacy and genetic discrimination, which is the main subject of this paper. If implemented without filling this vacuum, this legislation will remain only as a symbolic gesture.
The DNA Technology (Use and Application) Regulation Bill was passed in the Lok Sabha in the month of January 2020 and was placed in front of a Parliamentary Standing Committee. The main aim of this Bill is to provide for and regulate the use of DNA technology for identification of persons. There are plenty of grounds on which the Bill has been criticised, and most of them have also found their mention in the Standing Committee’s Draft Report. One of the first concerns regarding this Bill was the lack of infrastructure as well as an effective public defender system.
The Bill is of no use in such circumstances where there is a risk of improper handling of DNA and lack of expertise and appreciation of such evidence by legal practitioners and judges. The Bill lacks an automatic mechanism for deletion of genetic data or confirmation regarding the same, once an individual applies for deletion. The Bill also fails to provide for checks on the Regulatory Board which has been gifted with wide discretionary powers. It is quite unclear how the Bill takes into consideration the Right against Self-Incrimination.
Lastly, and most relevant, it raises concerns of communal profiling based on genetics. In the USA, DNA profiling in cases has resulted in aggravating stereotypes and increasing discrimination at the hands of investigating authorities. The Bill fails to allay fears of such discrimination happening. It is essential here to note that, as discussed earlier, some castes and communities in the Indian subcontinent as a result of inbreeding have developed certain genetic traits and mutations which are peculiar to them only. Therefore, such genetic discrimination based on DNA profiling will also result in caste-based discrimination. Some other concerns raised by the Standing Committee regarding the Bill include the absence of robust data protections, storage of DNA information of unconvicted persons and perfunctory consent wherein the Magistrate can override the consent in all provisions where it is mentioned, effectively weakening the whole point of having a consent-based system for storage of such sensitive information.
Genetic discrimination also becomes an intersectional issue specifically in countries where endogamous/ inter-community/ inter-caste marriages are prevalent because of the pre-existing discrimination happening with these groups; hence, with conscious efforts being made to eradicate such discrimination, prevention of genetic discrimination is also essential for it to work. The aim of legislations preventing genetic discrimination or misuse of genetic data is not to do away with such technology but to regulate it. For proper and fair regulation, these things need to be kept in mind: the concept of consent needs to be given more power – interpretation, grant and withdrawal, regulation includes regulating the government and its authorities and, lastly, comprehensive rules regarding deletion of such data.