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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

16 March 20088

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

16 March 200812

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

16 March 200813

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

16 March 200814

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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Kitasato International Symposium

16 March 200815

www.rejuvenationplus.com/

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Kitasato International Symposium

16 March 200817

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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