Beyond Medicine:

The Role and Limitation of Legal

Regulation for the Development of
Quality Genetic Testing Services

Prof David Weisbrot, ALRC President

Kitasato International Symposium 2008
ALRC-NHMRC joint inquiry
• In relation to human genetic information
– and the samples from which this is
derived – how can we best:
 protect privacy interests
 protect against unfair discrimination
 ensure the highest ethical standards
• Emphasis on public engagement

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 Application to many contexts
• Medical/scientific • Employment
research • Insurance
• Clinical genetics • Forensics
• Systemic health • Kinship and Identity
(immigration;
care issues parentage; ethnicity/
• Human genetic Aboriginality?)
databases, tissue • Other right, services
banks, registers (eg education, aged
care, sports)

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 Final Report – ALRC 96 (2003)
• 144 recommendations –
directed at 31 bodies,
including the NHMRC
• Dr Francis Collins,
NHGRI/NIH: ‘a truly
phenomenal job … placing
Australia ahead of what
the rest of the world is
doing’.
• Whole-of-Government
response on 9 Dec 05
accepted almost all
recommendations
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Genetics and public perceptions
Optimism about medical breakthroughs
• in diagnosis, treatment, prevention (eg, gene therapy,
‘smart drugs’) – affected families especially positive and
passionate
Anxiety about loss of control
• ‘mad science’ unrestrained by law, ethics or morality;
‘genetic essentialism’; eugenics
• commercialisation (Big Pharma = new Evil Empire?)
• may intensify gap between haves and have-nots?
• Australians have not lost faith in the possibility of
regulating biotechnology in the public interest …

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GATTACA

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 The policy approach
Not every problem requires ‘Big Law’:
• “successfully fulfilling this brief not only
involves providing adequate protections
against the unlawful use of genetic
information, but also putting into place
measures to ensure that where such
information may be used lawfully, it is
used properly, fairly and intelligently”

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 The regulatory approach
Use a sophisticated mix of strategies:
• legislation and regulations
• official standards and codes of practice
– eg NHMRC and Privacy Commissioner’s offical
Guidelines, laboratory accreditation standards
• industry codes and best practice standards
– insurance industry’s policy on genetic testing
• education and training
– community, med schools, continuing/specialist ed
• peer review
• funding incentives/disincentives
• better coordination of governmental programs
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 Key legal recommendations
• Some legal changes required
– To protect/preserve inherent rights and interests
– So important health choices not driven by collateral
matters (“Doctor, I can’t take that genetic test because I’m
worried it may affect my insurance”)
• Address anti-discrimination concerns
– Amend law expressly to cover unlawful discrimination
based on (real or perceived) genetic status
– employment, insurance, immigration, OH&S laws
• Adapt privacy laws
– ‘sensitive personal information’ requires strong protection
… but also shared information (familial dimension)
– extend law beyond data to cover genetic samples
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Delivering quality genetic services
Preparing for when ‘all medicine will be
genetic medicine’ requires a collaborative,
coordinated effort:
• Health Departments, hospital administrators
• Clinical geneticists (and researchers)
• GPs (and other specialist doctors)
– diagnosis (‘gatekeeping’); patient management
• Genetic counsellors (or Google?!)
– expert at communicating risk and options
• Genetic support groups
• Human Genetics Advisory Committee
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 Regulating access to testing
• DNA testing/analysis only by fully-
accredited laboratories
– no Medicare payments otherwise
– no evidentiary value otherwise (eg paternity tests)
• Identify ‘sensitive’ genetic tests
requiring restricted access, consent
regimes or counselling
– analogy with approach to restricted HIV-AIDS testing

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 Regulating illicit testing?
• Decreased cost, increased availability,
direct marketing, financial incentives 
encourage illicit testing
– eg, by parents, employers, insurers, investigators, media etc

• Recommend creating a new criminal

offence: submitting another person’s
DNA for testing without consent or other
lawful authority (eg court order, statute)
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 Regulating consumer curiosity?
• Directly-marketed DIY ‘lifestyle’ test kits
– CEO of Sciona, ‘You and Your Genes’:
‘already a lot of information out there recommending, for
instance, a diet high in fruit, broccoli and grains …
Consumers find this advice daunting, as they are not sure to
what extent it pertains to them as individuals.’
– ‘Nutrigenomics’ has now begat ‘dermagenetics’ (the ‘5
wrinkle genes’); sporting genes; ancestry; paternity
• Empowering? Worth worrying about?
– Regulation? Education? Buyer beware?
– (‘recreational genomics’; ‘feng shui genomics’)

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www.rejuvenationplus.com/

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 Other serious concerns
• Security – safe from hackers?
• Adequacy of ethical oversight
– 220+ institutional review boards in Australia
• Commercialisation
– intellectual property/patenting issues
– undisclosed ownership, conflicts of interest
• Access and equity
– since genetic medicine is expensive …

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 Lessons/conclusions
• Sensitive regulation needed to facilitate
advances in genetic research and the
development of quality clinical genetic services
– reassure public about ethics, autonomy, legal protections,
quality and integrity of system
– over-regulation  stifle innovation
– under-(or poorly targeted-) regulation  risk ‘horror
stories’ that cause panic  regulatory over-reaction

• Maintaining public support (and legitimacy) for

genetic medicine requires openness,
transparency and honest public debate.
Once trust is lost, it is very difficult to regain.
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 For further information
• ALRC website: all papers, reports
available (free) at:
<www.alrc.gov.au>
• Email: info@alrc.gov.au
• Post: GPO Box 3708
Sydney NSW 2001

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