Introduction

11.1 This chapter focuses on a range of issues concerning access to genetic testing.^[1] 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. Medical practitioners may request various types of genetic test, which may in turn require referral to a medical specialist, such as a clinical geneticist, or to a genetic counsellor.^[2] However, genetic testing products and services also may be provided by laboratories and others directly to the public.

11.2 The steps that individuals must take in order to obtain a genetic test vary according to the type of testing sought, the laboratory concerned, and whether there is a request from a health professional. The nature of these steps and the consequent ability of individuals to gain independent access to genetic testing may be constrained by laboratory practices and protocols, including those relating to accreditation requirements, and by ethical and professional standards applying to health professionals.

11.3 The chapter begins by describing the laboratory accreditation system, which seeks to ensure the technical proficiency of public and private genetic testing laboratories and the scientific reliability of the test results they produce. The chapter also considers ways in which accreditation standards can be enhanced to ensure high ethical standards in genetic testing.

11.4 The chapter then focuses on issues concerning the availability and use of genetic testing services provided directly to the public and, in particular, whether the supply and advertising of parentage and other kinship testing kits (whether for home or laboratory use) should be regulated by the Therapeutic Goods Administration.