General Principles and Logic of the Legal Regulation of Genetic Research in Australia

The paper deals with the features of the legal regulation of genetic research in the Commonwealth of Australia with due regard to the state structure, national, ethical and other factors. The primary source of law in Australia is the common law articulated in judicial precedents (case law) that has recently been supplemented by acts of statutory regulation. The paper thoroughly investigates the processes of storage, access and protection of full-genome sequencing data. The authors analyze the peculiarities of functioning of the judicial system of Australia; the experience of normative consolidation of informed consent for genetic research, confidentiality of obtained information, strategic priorities in integration of the results of genetic research into Australia’s health system. The paper provides the analysis of the list of documents containing indications of cases in which medical organizations should not collect confidential information about a person. As a result of the study, the authors identify certain gaps in the normative legal regulation of genetic research and inconsistencies and contradictions of certain normative legal acts. The paper focuses on specifics of genetic research with the participation of the Aboriginal population of Australia, which, in turn, will help in the formation of the relevant legal framework in the Russian Federation.

As a conclusion, the authors note that in the field of legal regulation of the processes of storage, access and protection of genetic information in Australia there is a tendency to use normative regulators. Particular attention is drawn to the normative consolidation of the priority of public interests over private interests and its reflection not only in numerous reservations and exceptions, but also in the framework of generally relevant strategic priorities. Presuming the development of the similar legal framework in the Russian Federation and taking into account the multiethnicity of the population, it should be highlighted that Australia’s experience in implementing the genetic research involving the Aboriginal population should be implemented.

1. Bohannon J. Genealogy Databases Enable Naming of Anonymous DNA Donors. Available from: http://DOI: 10.1126/science.339.6117.26 (cited 25 May 2020).

2. Burns BL, Bilkey GA, Coles EP, et al. Healthcare System Priorities for Successful Integration of Genomics: An Australian Focus. Front Public Health. 2019;7:41. Available from: https://DOI:10.3389/fpubh.2019.00041 (cited 25 May 2020).

3. Eckstein L, Chalmers D, Critchley C, et al. Australia: regulating genomic data sharing to promote public trust. HumGenet. 2018;37:583—591. Available from: https://doi.org/10.1007/s00439-018-1914-z (cited 25 May 2020).

4. Gymrek M, McGuire AL, Golan D, et al. Identifying personal genomes by surname reference. Science. 2013; 339:321—324. Available from: https://doi.org/10.1126/science.1229566 (cited 25 May 2020).

5. McWhirter R, Nicol D, Savulescu J. Genomics in research and health care with Aboriginal and Torres Strait Islander people. Monash Bioeth Rev. 2015; 33:203—209. Available from: https://doi.org/10.1007/s40592-015-0037-8 (cited 25 May 2020).