Global Challenges and Opportunities: the Australian Experience

Global Challenges and Opportunities: the Australian Experience

Prof David Weisbrot AM, Macquarie University and

US Studies Centre @ Sydney Uni

Tarrytown Meeting – Working Session III – 26 July 2011

Lisa EcksteinSJD Candidate, Georgetown

University Law Center

Australia: some basics• 22M people, urban concentration

– highly disadvantaged Indigenous population; problematic delivery of services to rural and remote areas

• Federal system (6 States, 2 Terrs + Cth) overly complex law / reg’n

• Comprehensive public healthcare system, including pharmaceuticals (although with some private elements)

• Even private health insurance (‘top-up’) is community-rated, and heavily subsidised (>$2B pa in public funding)

2Eckstein & Weisbrot - Tarrytown Meeting - 26 July 2011

ALRC-AHEC inquiry: the protection of human genetic information

• Medical/scientific research

• Clinical genetics• Systemic health care

issues (eg cost, training, equipment, genetic counsellors)

• Biobanks: human genetic databases, tissue banks, registers

• Employment• Insurance• DNA Forensics• Kinship and Identity

(immigration, parentage, ethnicity/Aboriginality)

• Other rights, services – eg education, aged care

• Sports

3

Focus on privacy, non-discrimination and ethical standards, in the contexts of:

Eckstein & Weisbrot - Tarrytown Meeting - 26 July 2011

Essentially Yours (ALRC 96, 2003)• Very extensive community

engagement/consultation– Strong spirit of altruism for

genetic research but concerns about loss of control

• 144 recommendations directed at 31 different bodies– Reject genetic exceptionalism

but recognise the special features and challenges of genetics

• Dr Francis Collins, NHGRI/NIH: ‘a truly phenomenal job … placing Australia ahead of what the rest of the world is doing’.

• Dec ’05: Govt response accepted almost all Recs; and steady implementation since


or GATTACA?


A national standing body (HGAC)(Per ALRC Rec) Human Genetics Advisory Committee of the National Health & Medical Research Council (NHMRC) established Jan 2006

• Recognises rapid change, need for continuing high-level advice to Govt, community, health professionals, industry & commerce

• Broad-based membership• HGAC has taken the lead on:– GP and community education– monitoring and working with insurance industry– DTC regulation – planning for the WGS era


Adapt privacy laws • ‘genetic information’ = sensitive, personal information,

requires highest level of protection under Privacy Act √• acknowledge the familial, shared nature of the

information (non-consensual disclosure?) √• add a new chapter to the National Statement on

human research ethics covering ‘biobanks’ √• extend the Privacy Act to cover identifiable tissue/DNA

samples (ie, go beyond ‘data’ protection) X• create new criminal offence for DNA testing without

consent or other lawful authority (eg court order, ethics-approved research, authorised police procedures) ?

Eckstein & Weisbrot - Tarrytown Meeting - 26 July 2011 8

Adapt anti-discrimination laws Disability Discrimination Act (Cth) amended (eff 8/2009): • DDA s4(1)(j) and the Workplace Relations Act now

expressly apply to discrimination based on (real or perceived) genetic status √

• Employers: cannot request or require genetic information from an employee or job applicant except where this information is reasonably required for purposes that do not involve unlawful discrimination √

• Insurance: exemption for risk-rating / underwriting only permissible if carried out on a ‘scientifically reliable and actuarially relevant’ basis √


ALRC 99: Genes & Ingenuity• ToR: 17 Dec 2002• 700 pp report tabled in

Parliament in Aug 2004• 50 recommendations• Influential overseas (AAAS,

OECD, UNESCO) • No formal Gov’t response

to date (many false alarms)• Separate Senate Inquiry in

2010 ( ALRC 99 recommendations should be implemented)


ALRC’s recommendations

• Ensure patents are not overly broad; isolated gene sequences are discoveries not ‘inventions’

• Utility: Increase onus on applicants to prove the ‘usefulness’ of their claimed invention

• Compulsory licences: allow courts to order a compulsory licence on competition grounds

• Statutory experimental/research use exemption• Take steps to preserve the public benefit/access

from publicly-funded research• Govt should play a more strategic role re IP in

genetic health (as it does re pharmaceuticals)


Patent Amendment (Human Genes and Biological Materials) Bill

Private Members Bill introduced 24/11/10: • ‘The purpose of this Bill is to advance medical and scientific research and the

diagnosis, treatment and cure of human illness and disease by enabling doctors, clinicians and medical and scientific researchers to gain free and unfettered access to biological materials, however made, that are identical or substantially identical to such materials as they exist in nature’.

• Proposed new limb of Patents Act s18(2) would provide:

The following are not patentable inventions: (a) human beings, and the biological processes for their generation; and (b) biological materials including their components and derivatives, whether isolated or purified or not and however made, which are identical or substantially identical to such materials as they exist in nature.

• Proposed s18(4) defines ‘biological materials’ to include ‘DNA, RNA, proteins, cells and fluids’

• Cancer Voices Australia & Anor v Myriad Genetics & Ors, pending in the Federal Court in September 2011. Arguing BRCA1/2 genes are discoveries, not ‘inventions’


DTC in Australia?• 5-6 private labs operating and marketing publicly, but

not quite DTC – they require a GP in the process (‘yours or ours’)

• One DTC lab (Lumigenix) hovering ... • One private health insurer promoted Navigenics to

members at 50% discount in Feb 2010 Therapeutic Goods Administration has just begun to regulate this field – new IVD framework announced (quietly) in July 2010– Human genetic testing public health risk based on

‘possible stress and anxiety relating to the information and/or follow-up measures’ ‘Class 3 IVD’ marketing and sale restrictions

• But then, of course, there’s the internet


Other noteworthy issues• Particular concerns of Indigenous peoples:– Biopiracy, relationship between DNA and

‘Aboriginality’, broader concerns about research ethics -> specific ethics review for research involving Indigenous people

• International/regional cooperation – Aust/NZ CER and Roundtable on Genomics– active regional meetings, discussions on ELSI– discussions with Japan and UK about DTC


Global Challenges and Opportunities: the Australian Experience

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