New Zealand Law Society - Better process needed for new genetic testing methods

Better process needed for new genetic testing methods

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New non-invasive tests for genetic abnormalities in pregnancy offer many advantages over traditional tests, but a new Law Foundation-backed study has found there should be a standardised process around their use.

The tests, which analyse a mother’s blood sample, have advantages over traditional screening tests: they are more accurate, available commercially, can be performed earlier in a pregnancy, and greatly expand the range of genetic conditions that can be screened for.

But the non-invasive tests also have risks. Principal Researcher, Jeanne Snelling, of the Otago University Bioethics Centre, says the ease of the new testing may make women complacent about the implications of a positive test.

Traditional screening, which has been available in New Zealand for many years, tests for conditions like Down Syndrome. The new screening tests can identify many other conditions, creating potentially greater decision dilemmas for expectant mothers.

“People need to understand that non-invasive screening can show false positives, so it needs to be followed up with the offer of invasive screening. It’s about ensuring that the clinical workforce is well informed enough to use non-invasive screening along with other forms of testing,” says Dr Snelling.

Dr Snelling says non-invasive prenatal testing (NIPT) is already available commercially in New Zealand, but oversight of tests depends on the standards in test manufacturing countries. These are variable – a review by the United States Food and Drug Administration reported that some manufacturers have inadequate pre-controls or post-surveillance to protect women.

Regulation of fast-moving NIPT technology is challenging and controversial. For example, despite the recognition of a constitutional right to abortion in Roe v Wade, some US states have introduced “reasons-based” abortion bans prohibiting abortions solely for foetal genetic abnormality, or extending immunities to doctors who withhold information from patients.

“Common law and the Consumers’ Code of Rights impose a duty on practitioners to inform patients about the implications of tests before they are taken, along with full disclosure of the results. But because of the speed of NIPT technology evolution, this may be difficult in practice,” says Dr Snelling.

Her study, The Future of Selective Reproduction: Ethics, Law and Public Interests, recommends that guidelines around NIPT use be standardised through the National Screening Committee.

“The tests are commercially-driven and the limitations of the tests are often not well understood by maternity care providers. We don’t need a law change as such, but policy makers and professional bodies need to ensure that testing is done within our medico-legal framework according to good standards.”

NIPT testing is expensive, at around $1,000 a test. Dr Snelling says some of the technology should be publicly funded, but implemented with a high-quality informed consent regime to ensure mothers fully understand its implications.

She says that providers should discuss with pregnant woman the kind of information that they want, or don’t want, rather than just “ticking all the boxes.”

“It is critical that women are made aware of the scope of expanded NIPT and the option to limit testing,” she says.

The recently-published research project is supported by the Advisory Committee on Assisted Reproductive Technology (ACART), an independent statutory expert body appointed by the Minister of Health. It is available in the publications section of the Law Foundation’s website www.lawfoundation.org.nz.

Lynda Hagen is Executive Director of the New Zealand Law Foundation.

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