Australia: Legal and ethical issues with genomic testing

Introduction - Genome Testing – Genome.One

An Australia-first genomic testing service that combines whole genome sequencing and a comprehensive health assessment can offer individuals an unprecedented glimpse into their future health.2

Launched in June 2017, by Sydney's Garvan Institute's Genome. One lab and corporate clinic Life First, the service offers individuals the ability to predict how they would likely react to more than 220 medications, allowing clinicians to better tailor treatment to their patients.

People with a niggling curiosity and $6,400 can now find out if their genetics and lifestyle has left them prone to developing a suite of life-threatening conditions including 31 types of cancer and 13 heart conditions across 230 genes.

Blood samples provide the raw material needed to sequence a patient's genome. Individuals also undergo a physical examination as well as pathology testing and a review of lifestyle risks like smoking, diet and alcohol intake.

Genetic counsellors guide patients through the process, explaining how the testing works, managing expectations and interpreting the results.

Genome.One provides a number of services, namely:

  • Personal health genomics - Personal health genomics analyses your genome (the entirety of a person's genetic material including all their genes) to provide you with a genomic profile. This profile can help you and your doctor to make personalised health decisions.
  • Disease diagnostics - Genomic testing may identify the gene variant(s) that causes a genetic condition. This diagnosis can confirm the patient's condition, and can help with prognosis and management of their medical condition. The Whole Genome Sequencing (WGS) is used to produce information across the genome for analysis and clinical interpretation.
  • Discover genomics - Discovery genomics services help position researchers at the forefront of genomic innovation for genomic exploration at scale.
  • Personal health applications - Precision medicine relies on sophisticated algorithms, integrated data sharing networks and highly accessible software interfaces. Precision health platforms can reduce costs and improve health outcomes for patients.

Ethical Challenges3

Whilst genomic testing brings the prospect of real benefits for patients and the potential to revolutionise diagnosis, screening, prevention and treatment, it also raises a number of ethical challenges, including the following:

  1. Equity of access – should access to genomic testing only be available to those who can afford to pay for it?
  2. Consent – can a person consent without knowing the full implications of what they are consenting to? With genomic testing, the boundaries of the possibilities of testing are constantly expanding.
  3. Confidentiality – the sharing of patient information is vital in order to assess the significance of individual genetic variants by comparing them to the norm. Genomic testing may test the boundaries of consent, particularly when information is known about one person, but could be of significant value to their family members and their health care providers.
  4. Availability for the greater good and adequate protection of genetic data – what if something is discovered of clinical significance to humanity? The uniqueness of our genetic data means that it can never be truly anonymous. Protections need to be put in place to reduce the risk of discrimination based on genetic characterisations.
  5. Patient choice – Many patients have suffered several years of delayed diagnosis. A genomic test may be able to provide information earlier so that treatment options can be introduced much earlier in the patient journey resulting in significant improvement of patient outcomes. In the future, should genomic testing be mandatory for the population to assist with health planning? However, people should have a right to privacy and many people may make the conscious choice not to be provided with information concerning their mortality. Ultimately, the challenge is to enable patients to have the choice. If they have the choice, then are they stealing from their family members their choice as well?
  6. Ownership – what if a particular individual's genome are so unique as to unlock a key in medical discovery. Should pharmaceutical companies own intellectual property rights and therefore monopoly rights involving the fabric of a person's genome?

Duty of care

Negligence means a failure to exercise care and skill. In an action for negligence, the plaintiff must prove that:

  • the defendant owed him or her a duty to take reasonable care;
  • the defendant breached that duty by failing to take reasonable care;
  • the defendant's breach of duty caused the injury or damage suffered by the plaintiff; and
  • the injury or damage suffered was not too remote as a consequence of the breach of duty.

The standard of care is now codified in Australia, for example under the Civil Liability Act 2002 (NSW) (Civil Liability Act). There is similar legislation in each State and Territory of Australia.

Section 5B of the Civil Liability Act states.

  1. A person is not negligent in failing to take precautions against a risk of harm unless:
    1. the risk was foreseeable (that is, it is a risk of which the person knew or ought to have known), and
    2. the risk was not insignificant, and
    3. in the circumstances, a reasonable person in the person's position would have taken those precautions.
  1. In determining whether a reasonable person would have taken precautions against a risk of harm, the court is to consider the following (amongst other relevant things):
    1. the probability that the harm would occur if care were not taken,
    2. the likely seriousness of the harm,
    3. the burden of taking precautions to avoid the risk of harm,
    4. the social utility of the activity that creates the risk of harm.

Does genomic testing expand what is reasonably foreseeable?

The standard of care for professionals is set out in section 5O of the Civil Liability Act:

  1. A person practising a profession (a professional) does not incur a liability in negligence arising from the provision of a professional service if it is established that the professional acted in a manner that (at the time the service was provided) was widely accepted in Australia by peer professional opinion as competent professional practice.
  2. However, peer professional opinion cannot be relied on for the purposes of this section if the court considers that the opinion is irrational.
  3. The fact that there are differing peer professional opinions widely accepted in Australia concerning a matter does not prevent any one or more (or all) of those opinions being relied on for the purposes of this section.
  4. Peer professional opinion does not have to be universally accepted to be considered widely accepted.

This Division does not apply to liability arising in connection with the giving of (or the failure to give) a warning, advice or other information in respect of the risk of death of or injury to a person associated with the provision by a professional of a professional service.

In future, will genomic testing become standard of care?

The duty to warn is identified as extending to "material risks" which may attend a proposed treatment. The risk is "material", relevantly for present purposes, if it is a risk to which a reasonable person in the position of the patient "would be likely to attach significance in choosing whether or not to undergo a proposed treatment".4

Except in cases of emergency or necessity, all medical treatment is preceded by the patient's choice to undergo it which choice is in reality, meaningless unless it is made on the basis of relevant information and advice.

Genomic testing may well influence the obligation of duty to warn for clinicians.

In our opinion, with genomic testing, three things will become critical:

  • adequate confidentiality and privacy protection and the need to obtain adequate consent;
  • the patient to be able to make an informed and conscientious choice as to the genetic information to be provided to him or her; and
  • appropriate genetic counselling.

Footnotes

2 Introduction sources: http://www.smh.com.au/national/health/australianfirst-whole-genome-sequencing-and-health-testing-open-to-public-20170619-gwtsgm.html; https://www.genome.one/
3 Source information includes: http://www.phgfoundation.org/blog/ethical-challenges-for-generation-genome

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

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