Global Challenges and Opportunities: the Australian Experience

1. Global Challenges and Opportunities: the Australian Experience Prof David Weisbrot AM, Macquarie University andUS Studies Centre @ Sydney Uni Lisa EcksteinSJD Candidate, Georgetown University Law Center Tarrytown Meeting – Working Session III – 26 July 2011

2. 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) Eckstein & Weisbrot - Tarrytown Meeting - 26 July 2011

3. ALRC-AHEC inquiry: the protection of human genetic information Focus on privacy, non-discrimination and ethical standards, in the contexts of: • 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 Eckstein & Weisbrot - Tarrytown Meeting - 26 July 2011

4. 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 exceptionalismbut 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 Eckstein & Weisbrot - Tarrytown Meeting - 26 July 2011

5. Eckstein & Weisbrot - Tarrytown Meeting - 26 July 2011

6. or GATTACA? Eckstein & Weisbrot - Tarrytown Meeting - 26 July 2011

7. 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 Eckstein & Weisbrot - Tarrytown Meeting - 26 July 2011

8. 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) ? 8 Eckstein & Weisbrot - Tarrytown Meeting - 26 July 2011

9. 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 onlypermissible if carried out on a ‘scientifically reliable and actuarially relevant’ basis √ Eckstein & Weisbrot - Tarrytown Meeting - 26 July 2011

10. 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) Eckstein & Weisbrot - Tarrytown Meeting - 26 July 2011

11. 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) Eckstein & Weisbrot - Tarrytown Meeting - 26 July 2011

12. 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’ Eckstein & Weisbrot - Tarrytown Meeting - 26 July 2011

13. 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 2010Therapeutic 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 Eckstein & Weisbrot - Tarrytown Meeting - 26 July 2011

14. 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 Eckstein & Weisbrot - Tarrytown Meeting - 26 July 2011