11. Regulating Access to Genetic Testing
11–1 In order to complement existing pathology laboratory accreditation arrangements, the Commonwealth, States and Territories should enact legislation to require laboratories to: (a) be accredited for any genetic test that they conduct for medical, diagnostic or treatment purposes; and (b) comply with the relevant accreditation standards. The legislation should make provision for exemptions in appropriate circumstances, such as for genetic tests performed by research laboratories.
11–2 While the primary focus of laboratory accreditation should remain on matters of technical proficiency and scientific reliability, the National Pathology Accreditation Advisory Council (NPAAC) should continue to develop ethical standards for medical genetic testing, in consultation with the Human Genetics Commission of Australia and the National Health and Medical Research Council.
11–3 NPAAC, in consultation with the National Association of Testing Authorities, Australia (NATA) and the Royal College of Pathologists of Australasia (RCPA), should examine how compliance with its accreditation standards in relation to consent, counselling and other ethical considerations in medical genetic testing should be assessed as part of the NATA/RCPA accreditation process.
11–4 NATA, in consultation with the RCPA, should develop training programs to equip its officers and peer assessors to verify compliance with NPAAC accreditation standards relating to consent, counselling and other ethical considerations.
11–5 The Commonwealth should amend the Therapeutic Goods Act 1989 (Cth) (Therapeutic Goods Act)and regulations made under that Act to enable the Therapeutic Goods Administration (TGA) to regulate more effectively in vitro diagnostic devices used in genetic testing provided directly to the public.
11–6 The Commonwealth should amend the Therapeutic Goods Act and regulations made under that Act to enable the TGA to regulate DNA identification test kits used in genetic testing provided directly to the public, including for parentage and other kinship testing.
11–7 The HGCA should develop codes of practice and advice relating to technical and ethical standards for genetic testing services provided directly to the public, including advice to the TGA or its statutory advisory committees.
12. A New Criminal Offence
12–1 The Standing Committee of Attorneys-General should develop a model criminal offence relating to non-consensual genetic testing, for enactment into Commonwealth, state and territory law. 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 individual from whom the sample has been taken did not consent to such testing.