28.07.2010
Chapter 10 observes that genetic testing can be divided into three broad categories based on the purpose of the testing, namely: medical testing, identification testing and kinship testing. Medical testing includes diagnostic testing; predictive or presymptomatictesting; genetic carrier testing; screening testing; pre-implantation and prenatal testingand testing for medical or scientific research. Identification testing or forensic testingis mainly performed on the non-coding portion of the human genome, to construct a ‘DNA profile’. This identification process is used in criminal investigations to exclude or identify a suspect, in searches for missing persons, and in the identification of deceased persons. These categories are not fixed—genetic testing sought for one purpose can sometimes reveal unintended information, such as where a medical test reveals incidental information about parentage (or, more sensitively, about misattributed parentage).
Chapter 11 considers a range of issues concerning access to genetic testing. To date, medical practitioners have been the primary ‘gatekeepers’ of access to genetic testing and the genetic information derived from it, at least for clinical purposes. Genetic testing for medical purposes usually requires a referral from a medical practitioner. However, genetic testing products and services also may be provided directly by laboratories, and testing kits increasingly are being marketed directly to the public.
Chapter 11 describes the laboratory accreditation system and makes recommendations aimed at requiring laboratories to be accredited and to enhance accreditation standards to ensure high ethical standards in genetic testing. The chapter then focuses on issues concerning the availability and use of genetic testing services provided directly to the public. The Inquiry recommends reforms to enable the TGA to regulate the products used in genetic testing provided directly to the public more effectively, including DNA identification test kits, used in parentage and other kinship testing.
Chapter 12 examines the serious ethical and privacy concerns that arise from non-consensual testing. A great deal of sensitive, personal information can be derived from genetic testing of a bodily sample, with important health, legal, and social implications for individuals, families and others. Access to genetic testing is now readily and increasingly available. Existing law provides only limited protection against non-consensual testing.
The Inquiry concludes that there should be additional legal protection against the unauthorised testing of genetic samples and, to this end, recommends a new criminal offence for enactment into Commonwealth, state and territory law. The Inquiry recommends that criminal liability should attach to any individual or corporation that, without lawful authority, submits a sample for genetic testing, or conducts genetic testing on a sample, knowing (or recklessly indifferent to the fact) that the person from whom the sample was taken did not consent to such testing.