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8/14/2019 David Weisbrot, Ph.D Role and Limitation of Legal Regulation for the Development of Quality Genetic Testing Services
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Beyond Medicine:
The Role and Limitation of LegalRegulation for the Development of
Quality Genetic Testing Services
Prof David Weisbrot, ALRC President
Kitasato International Symposium 2008
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Kitasato International Symposium
16 March 20082
ALRC-NHMRC joint inquiry
In relation to human genetic information and the samples from which this isderived how can we best:
protect privacy interests
protect against unfairdiscrimination
ensure the highest ethical standards
Emphasis on public engagement
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Kitasato International Symposium
16 March 20083
Application to many contexts
Medical/scientificresearch
Clinical genetics
Systemic healthcare issues
Human geneticdatabases, tissuebanks, registers
Employment Insurance
Forensics
Kinship and Identity
(immigration;parentage; ethnicity/Aboriginality?)
Other right, services(eg education, aged
care, sports)
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Kitasato International Symposium
16 March 20084
Final Report ALRC 96 (2003)
144 recommendations directed at 31 bodies,including the NHMRC
Dr Francis Collins,NHGRI/NIH: a trulyphenomenal job placingAustralia ahead of whatthe rest of the world isdoing.
Whole-of-Governmentresponse on9 Dec 05
accepted almostallrecommendations
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Kitasato International Symposium
16 March 20087
GATTACA
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Kitasato International Symposium
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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 unlawfuluse 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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Kitasato International Symposium
16 March 20089
The regulatory approach
Use a sophisticated mix of strategies:
legislation and regulations official standards and codes of practice
eg NHMRC and Privacy Commissioners officalGuidelines, laboratory accreditation standards
industry codes and best practice standards insurance industrys 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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Kitasato International Symposium
16 March 200810
Key legalrecommendations
Some legal changes required To protect/preserve inherent rights and interests
So important health choices notdriven by collateralmatters (Doctor, I cant take that genetic test because Imworried 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 geneticsamples
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Kitasato International Symposium
16 March 200811
Delivering quality genetic services
Preparing for when all medicine will begenetic 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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Kitasato International Symposium
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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)
Identifysensitive genetic tests
requiring restricted access, consent
regimes or counselling analogy with approach to restricted HIV-AIDS testing
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Kitasato International Symposium
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Regulating illicittesting?
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 persons
DNA for testing without consent or other
lawful authority (eg court order, statute)
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Kitasato International Symposium
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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, forinstance, a diet high in fruit, broccoli and grains Consumers find this advice daunting, as they are not sure towhat extent it pertains to them as individuals.
Nutrigenomics has now begat dermagenetics (the 5wrinkle 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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Lessons/conclusions
Sensitive regulation needed to facilitate
advances in genetic research and thedevelopment 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 horrorstories that cause panic regulatory over-reaction
Maintaining public support (and legitimacy) forgenetic medicine requires openness,transparency and honest public debate.Once trust is lost, it isvery difficult to regain.
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