Human Genomics in Global Health

Quality and Safety in Genetic Testing: An Emerging Concern

Joint Regulation of Genetic Testing : Australia and New Zealand

Australia and New Zealand are making moves towards joint regulation of genetic testing through a more general arrangement, the Trans Tasman Mutual Recognition Agreement (TTMRA) (1) implemented in 1998 to facilitate trade between Australia and New Zealand. Already many joint systems for regulation are in place. For example, National Association of Testing Authorities, Australia (NATA) and International Accreditation New Zealand (IANZ) have signed an agreement of mutual recognition, so that any laboratory accredited by one body is recognized as accredited by the other. This will allow more freedom for cross-border testing between Australia and New Zealand, and address issues of under-resourcing by resource sharing. The basis of this recognition are the National Pathology Accreditation Advisory Council (NPAAC) guidelines for laboratory accreditation used by both IANZ and NATA. The NPAAC guidelines were developed under the influence of three Australasian bodies: the Royal College of Pathologists of Australasia (RCPA), the Human Genetics Society of Australasia (HGSA), and the Australasian Society of Genetic Counsellors (ASGC). The details of the guidelines are as follows:

The NPAAC document includes standards for: Laboratory ethics; quality systems; staffing, supervision and consultation; facilities; test ordering, analysis, and follow-up; occupational health and safety; and internal and external auditing for quality assurance (2). NPAAC standards require laboratories to undergo external quality assurance testing programs, and to perform to an acceptable standard in those programs (3). Data from these programs are made available to NATA during assessment (4). Where there is no external proficiency program available, labs are required to undergo inter-laboratory comparisons and/or analysis of reference and control materials (5). The NPAAC standard for laboratory ethics (6) requires that patient wellbeing and confidentiality be the primary considerations of the lab when performing tests. This means that no person should disclose patient or test information to anyone other than the requesting medical practitioner, or other medical practitioner currently treating the patient (as dictated by privacy legislation). It is also required that there be policies and procedures in place to maintain the ethical standards of the laboratory. Finally, NPAAC requires that human samples, tissues and remains be treated with due respect. It is the responsibility of the lab to ensure that the quality of their work is not affected by any improper pressure, be it financial, commercial, or otherwise.

Also as part of the TTMRA, a joint proposal for a trans Tasman agency for the regulation of therapeutic products (7) has been accepted by both the Australian and New Zealand governments, and is set to be implemented in July 2006 (8) . In Australia, this new agency will replace the Therapeutic Goods Administration (TGA) (9) , in accordance with the Therapeutic Goods Act (1989) (10) ; in New Zealand it will replace the New Zealand Medicines and Medical Devices Safety Authority (Medsafe) (11) , which operates in accordance with the New Zealand Regulatory Guidelines for Medicines (12) developed from the Medicines Act 1981 (13) and parts of the Misuse of Drugs Act 1975 (14) . These agencies indirectly ensure the quality and safety of genetic testing by regulating some of the kits and products used to administer those tests under the classification of in vitro diagnostic (IVD) devices.