Evaluating the regulatory framework

Issues and problems

35.60 The Inquiry received many submissions expressing concerns about the regulation of parentage testing in Australia. These concerns related both to testing conducted under the family law scheme and to unregulated testing conducted by accredited and non-accredited laboratories. Arlette Mercae suggested:

The availability of mail order paternity tests from unlicensed laboratories can only jeopardise the well being of the child. Careful regulation of the circumstances under which paternity tests can be sought, and adequate counselling for the whole family should be put in place. This is primarily to ensure the security and physical and emotional welfare of the child, whose needs in this situation should be paramount, not those of the parents.^[64]

35.61 Colin Andersen submitted that the debate so far has been narrowly focused on the activities of non-accredited, as opposed to accredited laboratories. He emphasised the need for reform not only of the non-accredited sector of the parentage testing industry, but also of the accredited sector.

Whatever regulatory regime is eventually adopted in Australia it has to be recognised that reining in the non-accredited laboratories alone is not in itself sufficient to clean up the industry—the practice of accredited agencies is also wanting, especially in allowing the unilateral, non-consensual initiation of paternity testing by mothers whose aim is to ensure that ex-husbands also become ex-fathers.^[65]

35.62 On the other hand, the Inquiry was informed that one of the benefits of testing outside the family law framework is that it is cheaper. Dr Geoffrey Edelsten, director of Gene-e Pty Ltd, submitted that accredited parentage testing involves high costs because of the legal costs involved in obtaining a parentage testing order and the actual cost of the accredited test.^[66] The Inquiry heard that another benefit of testing outside the family law framework is that it allows parents to conduct ‘peace of mind’ testing without causing potentially unwarranted concern to the child or the family.^[67]

35.63 The Inquiry received several submissions addressing concerns about the accuracy and reliability of parentage testing conducted by both accredited and non-accredited laboratories. The author of one submission gave examples of alleged tampering with bodily samples, as well as alleged deliberate false reporting by a number of Australian accredited and non-accredited laboratories. The author raised concerns that current safeguards for protecting the integrity of the samples do not protect against tampering or deliberate fraud.^[68]

35.64 Another submission emphasised the opportunity and temptation for parents to obtain falsified results:

There seems to be secrecy about the tests in Family Law cases (the mother, for instance, may not be present during the testing). There are few safeguards, and it would seem that accreditation of testers is haphazard and loose. Moreover … there are ample opportunities for contamination, mislabelling and degradation of samples … A man who fathers a child outside marriage can expect to pay child support for at least 18 years. Depending on the relevant factors in the child support legislation and the Family Law Act, and inflation, his total liability is likely to be at least $500,000 … The temptation to obtain false testing must be great.^[69]

35.65 The Inquiry also heard of alleged cases of sample substitution, in which the putative father sent a substitute man, and in another case, the child’s mother sent a substitute woman and child, to provide the bodily samples in order to obtain paternity exclusions.

Options for reform

35.66 There are two different approaches to the regulation of parentage testing. The first involves regulating access to genetic testing by imposing an additional hurdle between the individual seeking the test and the laboratory doing the testing—for example, a court order or the authorisation of a medical practitioner. The second approach preserves the right of individuals to make a direct approach to a laboratory, but seeks to regulate the laboratories themselves—for example, by requiring laboratories to be accredited or comply with an industry code of practice.

Court supervision

35.67 The option of using court supervision would make access to parentage testing subject to a parentage testing order under the FLA, or relevant state and territory legislation. This would enable the courts to provide independent oversight of the testing, including in relation to the validity of consent. Several submissions supported this approach.^[70] The HGSA suggested the courts could ensure both the accuracy and reliability of the evidence admitted and a mechanism to address issues arising from the test results.^[71]

35.68 However, using a court in every case may be expensive, slow or inconvenient. While Family Court proceedings may be confidential, by necessity they require individuals to place sensitive information in the public arena—at least to the extent of being heard by those present in court. Additionally, there are constitutional difficulties in utilising federal courts to make orders in cases where parentage testing is not related to a legal dispute between parties.

Medical practitioners as gatekeepers

35.69 An alternative would be to make medical practitioners the ‘gatekeepers’ of parentage testing conducted by Australian laboratories by specifying appropriate request pathways. Medical practitioners would be well placed to take a bodily sample from each person involved in the testing procedure, to protect the integrity of the samples, and to ensure informed consent is given by those from whom it is required. However, parentage testing is not inherently related to the health of the parties concerned. Involvement of medical practitioners might be seen as compelling doctors to divert their resources to the provision of a social service that is unrelated to their medical expertise and more appropriately provided by others.

NATA accreditation

35.70 A principal advantage of NATA is that is provides an industry-based mechanism for independent oversight of laboratories that conduct genetic testing. A disadvantage is that current accreditation standards focus mainly on technical proficiency and do not address the ethical issues associated with testing.

35.71 The Inquiry addressed this issue in Chapter 11, where it recommended that National Pathology Accreditation Advisory Council, in consultation with 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.^[72]It should be noted, however, that NATA accreditation standards currently make provision for protecting the integrity of the sample in parentage testing by adopting the requirements of the FL Regulations.

Code of practice

35.72 A final option would be to implement a voluntary code of practice for parentage testing conducted by Australian laboratories. The United Kingdom’s Department of Health has implemented such a code, which applies to all organisations advertising and providing genetic paternity testing services direct to the public.^[73] Several submissions supported this option.^[74] However, the greatest drawback of such a system is that it is not legally enforceable. Concerns about compliance have led the United Kingdom’s Human Genetics Commission to recommend a review of the effectiveness and relevance of the Code of Practice.^[75]

Submissions and consultations

NATA accreditation

35.73 In DP 66, the Inquiry noted its preliminary view that DNA parentage testing should be conducted only by NATA accredited laboratories, and only in accordance with NATA accreditation standards.^[76] Adoption of this policy would eliminate DNA parentage testing that is currently performed in Australia by non-accredited laboratories. It would also eliminate the practice of allowing NATA accredited laboratories to conduct non-accredited parentage testing by the expedient of not holding themselves out as being accredited for the purposes of a particular test.

35.74 Most of the submissions addressing this proposal expressed their support.^[77] The Reliable Parents (Inc) commented that it

recognises the importance of both scientific and ethical standards to ensure that the results of paternity testing are as accurate as possible. The social implications of an error or substitution in a testing procedure require that the highest standards be maintained.^[78]

35.75 Both Sydney IVF Limited and the Genetic Technologies Corporation Pty Ltd (Genetic Technologies)^[79] submitted that only NATA accredited laboratories should be permitted to conduct DNA parentage testing.^[80] However, Genetic Technologies commented that if the NATA guidelines are changed to preclude some kinds of parentage tests, for example ‘motherless tests’, they would not support the proposal, noting that:

even though we do offer testing outside the NATA guidelines, this is not done in complete ignorance of them. It would be undesirable, for example, to test samples without evidence of consent, and we do not do this. Additionally, we ensure that samples are collected with as high a degree of integrity as possible. Once in the laboratory, the sample is tested to exactly the same technical standards as if it were obtained in accordance with NATA guidelines of testing.^[81]

35.76 NATA advised the Inquiry that in practice some accredited laboratories offering non-accredited testing do not follow the same standards and procedures in relation to non-accredited tests.^[82]

Review of the ethical and technical requirements

35.77 The consequences of parentage testing can be of profound significance to the persons tested and to others whose parentage status is affected by the test results. DP 66 proposed that both the NATA accreditation requirements for DNA parentage testing, and Part IIA of the FL Regulations, should be reviewed to ensure that they meet the highest technical and ethical standards, particularly in relation to consent to testing, protecting the integrity of genetic samples, and provision of counselling.^[83]

35.78 Most of the submissions addressing these proposals expressed their support.^[84] NATA supported the proposal, advising that a review of the accreditation criteria is being planned and the issues raised in DP 66 would be considered in that review.

In particular, those requirements currently covered by the Family Law Requirements (for example, requirements for the collection and security of samples) will be incorporated to make the accreditation program applicable to parentage testing outside that performed for Family Law purposes.^[85]

35.79 The New South Wales Legal Aid Commission commented that the improvement of identification and security standards to protect the integrity of samples, and the provision of information and counselling, are particularly important.^[86] Sydney IVF Limited commented that:

the exacting requirements necessary to perform genetic testing on humans should adequately cover the collection of specimens, the chain of custody, appropriate laboratory testing protocols, reporting protocols and storage of retained specimens and laboratory records. Given the impact that the results of parentage testing can have on mother, purported father and child, the highest level of sample and testing control should be required.^[87]

35.80 Genetic Technologies questioned whether NATA is the most appropriate organisation to determine ethical standards for parentage testing, and requested clarification whether the FL Regulations would be developed separately to the NATA guidelines in relation to this issue. It was suggested that the Inquiry should exercise caution in introducing too much complexity into the regulation of parentage testing.^[88]

Inquiry’s views

35.81 Despite the support expressed in several submissions for court supervision of parentage testing in every case, the Inquiry considers that this approach would be overly prescriptive. The cost, delay and potential exposure of a court order is likely to act as a deterrent to testing, or to force interested persons ‘underground’ to unregulated parentage testing available through mail order or over the Internet.^[89] The Inquiry is also of the view that it is not appropriate to expect medical practitioners to provide a range of social services in relation to a genetic testing procedure that is largely unrelated to the present or future health of the sample donors.

35.82 While the introduction of a code of practice has been suggested, the Inquiry is concerned that the voluntary nature of the code would permit laboratories to continue offering non-accredited testing that may not meet minimum technical and ethical requirements. Some laboratories may maintain the high standards required of accredited testing when conducting non-accredited tests but this may not be the case in all laboratories.

35.83 The consequences of parentage testing can be of profound significance to the individuals tested and to others whose parentage status is affected by the results of the test. Test results may lead to the destruction of long-standing social relationships between adults and children, and between partners in a relationship. As noted above, significant financial consequences may turn on the results. It is essential in this context to ensure that parentage testing is performed to the highest standards of technical proficiency and in accordance with sound ethical principles.

35.84 In the Inquiry’s view, these objectives can be achieved by requiring all parentage testing in Australia to be performed by NATA accredited laboratories in accordance with NATA standards, provided those standards are upgraded to address the full range of scientific and ethical concerns, such as procedures for protecting the integrity of the sample, consent to testing, and the provision of information about the availability of counselling.

35.85 To that end, the Inquiry recommends that:

• The Commonwealth should enact legislation to provide that DNA parentage testing in Australia is conducted only by laboratories accredited by NATA, and only in accordance with NATA accreditation requirements.
• NATA should review its accreditation requirements for DNA parentage testing to ensure that they meet the highest technical and ethical standards, particularly in relation to consent to testing, protecting the integrity of genetic samples, and providing information about counselling.
• The Commonwealth should review Part IIA of the FL Regulations to ensure that the requirements for parentage testing meet the highest technical and ethical standards, particularly in relation to consent to testing, protecting the integrity of genetic samples, and providing information as to counselling.

35.86 To minimise uncertainty or complexity between these two regulatory frameworks, the Inquiry recommends that in reviewing Part IIA of the FL Regulations, the Commonwealth should have regard to the accreditation requirements for DNA parentage testing developed by NATA in accordance with Recommendation 35–2.