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Should there be legal limits to genetic testing? Who should or should not be tested and why? For example, does the Law have a role to play in prohibiting or facilitating testing for traits such as height, intelligence, sporting ability, alcoholism, asthma, and breast cancer?



Genetic testing has always been a sensitive issue and often poses legal, sociological, and ethical questions. Genetic testing has advanced a lot in the 21st century because of sheer advancement in medical technology. Usually, genetic testing is done on an embryo, a pregnant woman for prenatal tests, a newborn, or a child. The article "Genetic Testing for Children and Adolescents", focuses on the ethical, legal, and psychological implications of testing children and young adults to identify any predispositions to genetic disorders. The article ranges from parents' restrictions and limitations on their children regarding genetic testing to the legal and ethical position on minors and adults. The article also discusses various risks associated with genetic testing and clinical ethics and guidelines regarding genetic testing maintained by health care practitioners.


The main question arises in genetic testing:how much role a parent plays in the genetic testing of their child? Like, the World Health Organisation, the American Society of Human Genetics, and the Nuffield Council of Bioethics, Australian legislation does not provide any specific law or guidelines regarding genetic testing on children. However, the Australian Medical Association and the United Nations Convention on the Rights of Child, of which Australia was a member, amplified it that the child can give legal consent to genetic testing after becoming an adult and can also question the fairness and partiality of a genetic test after turning into an adult on a reasonable basis. It was also said in the convention that the interests of children should be protected and must not be compromised in any manner.


In another article, "Points to Consider: Ethical, Legal and Psychosocial implications of Genetic Testing in Children and Adolescents"this article analyses and dissects the ethical, legal, and social issues surrounding the issues of genetic testing on children and adults. This article has further highlighted the impact on an individual's psychological and mental well-being and the social stigma. The article also talks about the legal authority for genetic testing on their children. The article has also explored the ethical guidelines and recommendations that medical practitioners and healthcare providers mustconsider when doing medical testing. According to the NHMRC (National Health and Medical Research Council) statement, one must consult the potential implications of genetic testing before taking or undergoing a DTC (Direct to Consumer) genetic testing. 


NHMRC's Medical Genetic Testing: Information for Health Professionals prescribed effective guidelines and highlights ethical, legal, and social issues resulting from the genetic testing and how healthcare professionals provide the best support to the patients, such as providing follow up medical advice, assisting the patients in need and ordering the appropriate genetic test. When it comes to the genetic testing on children and adolescents for identifying various traits such as height, intelligence, and sporting ability, recently, the Australian Institute of Sports, in a statement published in the British Journal of Sports Medicine, has warned strictly against the genetic testing for the sporting ability of the children under the age of 18. However, the Law does not have much say regarding it. 


Legal implications and role in genetic testing (Australian Law Context)

Australian Law and legislation currently do not provide much protection and legal restrictions for genetic testing. Australia does not have any national statement policy on population genetic screening. However, NHMRC and the Royal Australian College of General Practitioners (RACGP) have provided some guidelines, which are widely accepted. Some state governments of Australia have also produced guidelines regarding the ethical screening of newborn babies for congenital genetic disorders. These guidelines are likeVictorian guidelines. According to these guidelines, parents have the right to legally refuse genetic testing of their newborn baby by signing a written legal consent. These guidelines also provide that the participation of parents in the screening programs is not necessary.


According to the NHRMC guidelines on ethical genetic testing,written consent on paper is required for genetic population screening. The genetic population screening is subjected to Section 14 of the Common Wealth Privacy Act, 1988,which governs how sensitive personal information is collected, stored, used, and disclosed by various governmental departments and agencies. 


According to the Australian Medical Association (AMA), genetic testing can only be undertaken with the patient's prior written consent or from the patient's legal guardian or substitute decision-maker if the patient cannot give his consent. The patient can legally deny or withdraw from genetic testing if they anticipate any bodily authoritative infringement or fear that certain information can be misused.


According to the 2012 AMA guidelines on genetic testing, children should be refrained from undergoing genetic testing by their parents and should wait till an age where a child can himself make an informed decision without the authority of their parents. No person can compel anyone to undergo genetic testing.


According to the Therapeutic Goods Act, 1989, all the nutrigenetic genetic testing (effect of nutrients on molecular cellular level) comes under the therapeutic goods and must comply and adhere with all the legal requirements given under the Act. All the nutrigenetic acts are regulated under the IVD (In-vitro devices) framework of Therapeutic Goods (Medical Devices) Regulations 2002. This prohibits and legally restricts the supply of self-testing genetic testing IVDs (In-Vitro Devices). All the medical devices under this Act must comply with all the safety and ethical requirements given under this Act.


Certain legal exclusion according to the Australian Law regarding the disclosure of genetic testing results

Generally, the results of genetic testing are highly private and confidential. They can only be disclosed under exceptional circumstances and according to the guidelines mentioned in the NHMRC's publication of Use and disclosure of genetic information to a patient's genetic relatives under Section 95AA of the Privacy Act, 1988- guidelines for health practitioners in the private sector.


In Australia, discrimination based on genetic status is prohibited, but one exception is allowed in the case of insurance claims. It is legally allowed but frowned upon on an ethical basis. A person is mandatorily required to disclose their genetic testing result otherwise, the third party holds legal authority and can deny the coverage of insurance and can impose high insurance premium claims. Insurance companies in Australia can use genetic results to discriminate against applicants for life, permanent disability, and income protection insurance with little to no consumer privacy. Under the National Health Act, 1953, private insurers are freely allowed to use the community ratings to determine the levels of their premiums. 


Insurance contracts are taken in good faith under the Insurance Contracts Act, 1984. The people raised several issues regarding discrimination against them, especially regarding their mental health by insurance companies in Australia.


Legal Case laws related to Genetic Testing 

 Breen Vs Williams

This is one of the famous landmark cases in Australian Law. In this case, the ethical implication of genetic testing is described. The high court reaffirmed an obligation of confidentiality on health care providers and workers not to disclose any confidential genetic information or results to a third party. In his dissenting judgment, the judge held that the doctor-patient relationship is fiduciary. A patient is entitled to legal and reasonable access to examine and copy the doctor's record.


This case also held that any change in Law or regulation must be for the parliament.


Jack Lowe and Dennis Reynolds Vs Atlas Logistics Group Retail Services (Atlanta) LLC

This case is famously known as the "Devious Defecator" case. This is one of the landmark cases in USA law. This case raised an important question regarding the confidentiality of genetic information, "Whether DNA taken from cheeks can be constituted as genetic information under GINA"? GINA is the Genetic Information Non-Discrimination Act. Under this Act, the company is prohibited from requesting or disclosing any genetic information.


The court ruled in favour of the plaintiff and held that the swab taken from cheeks cells is genetic information.


Critical Analysis and Conclusion

The current existing legal framework related to genetic testing in Australia provides little coverage and protection for genetic testing in Australia. The privacy act should be broadened and extended to provide legal and enforceable privacy standards for handling genetic materials.


There is a need for additional legal protection against discrimination based on genetic results and unauthorised handling. There is also a need to internalise a strong ethical dimension to uphold the ethical protection for genetic testing, as ethics play an important role in genetic testing. 



A Legislation/Bills/ Statutes

  • The Privacy Act 1988
  • Australian Constitution
  • The Age Discrimination Act 2004
  • Commonwealth Disability Discrimination Act 1992
  • Insurance Contract Act 1984
  • Therapeutic Goods Act 1989
  • Genetic Information Non-Discrimination Act 2008
  • Common Wealth Privacy Act 1988
  • Genetic Privacy Bill 1998


B Journals/Websites/Articles

  • Australian Law Reform Commission, Parliament of Australia, Essentially Yours: The Protection of Human Genetic Information in Australia (2010)
  • 'Australian Government Department of Health Therapeutic Goods Administration', The Therapeutic Goods Act 1989 & the Poisons Standard (Web Page)
  • 'National Health Medical Research Council', DNA Genetic Testing in the Australian Context (pdf)
  • Natalia Meggiolaro et al Kristine-Barlow-Stewart, Kate Dunlop, Ainsley J. Newson and Jane Fleming, 'Disclosure to genetic relatives without consent- Australian genetic professionals' awareness of the health privacy law' [2020] BMC Medical Ethics
  • 'Updated policy on genetic testing and genomics in medicine',Australian Medical Association (Web Page, 1 Sep 2020)
  • Natasha Gilbert, 'Why the devious defecator is a landmark for US genetic-privacy law' [2015] Nature
  • 'The regulation of nutrigenetic tests in Australia', Australian Government Department of Health Therapeutic Goods Administration'(Web Page, 16 January 2019)
  • Australian Law Reform Commission, Parliament of Australia, Genes and Ingenuity: Gene patenting and human health (2010)
  • 'Australia Government National Health and Medical Research Council', Discussing Direct to-Consumer Genetic DNA Testing with Patients: A Short Guide for Health Professionals (Pdf December 2013)
  • Carolyn Riley Chapman et al Kripa Sanjay Mehta, Brendan Parent and Arthur L Caplan, 'Genetic Discrimination: emerging ethical challenges in the context of advancing technology' (05 December 2019) 7 Journal of Law and the Biosciences 1
  • Jeffrey R. Botkin, John W. Belmont, Jonathan S. Berg, Benjamin E. Berkman, Yvonne Bombard, Ingrid A. Holm, Howard P. Levy, Kelly E. Ormond, Howard M. Saal, Nancy B. Spinner,  Benjamin S. Wilfond and Joseph D. Mclnerney, 'Points to Consider: Ethical, Legal, and Psychological Implications of Genetic Testing in Children and Adolescents (2015) 97 The American Journal of Human Genetics 1
  • 'AIS warns against genetic testing for talent ID in children'SportsAus (Web Page 02 December)
  • Jane Tiller, 'Genetic discrimination by Australian insurance companies: a survey of consumer experiences' [2019] European Journal of Human Genetics
  • Sara Bird, 'Genetic testing: medico-legal issues' (2014) 43 Australian Family Physician 7
  • Jane Tiller and Paul Lacaze, 'Australians can be denied life insurance based on genetic test results, and there is little protection'The Conversation (Web Page 25 August 2017)

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