Australian Law Reform Commission

Terms of reference

In relation to human genetic information and samples, how can we best:

• protect privacy

• protect against unfair/unlawful discrimination

• ensure highest ethical standards in research and clinical practice

Application to many specific contexts

• Medical research

• Clinical practice

• Systemic health care issues

• Genetic databases, tissue banks, registers

• Employment

• Insurance

• Identity/kinship (immigration, parentage testing)

• Law enforcement

Inquiry processes

• Terms of Reference – Feb 2001

• Expert advisory committee(s)

• Research – national, international

• Community engagement

• 15 public forums, 200+ meetings, lots of media

• Written submissions (317+)

• Consultation papers (IP 26, DP 66)

• Final report (completed; to be tabled)

• Implementation?

General ALRC implementation rates

• Substantial Implementation [n37-56%]

• Partial Implementation [n15-23%]

• Nil Implementation [n10-15%]

• Proposals under consideration [n4-6%]

Genetics and social ambivalence

Optimism about medical breakthroughs

• in diagnosis, treatment, prevention (eg, gene therapy, ‘smart drugs’) – affected families especially passionate

Anxiety about loss of control

• ‘mad science’ unrestrained by law, ethics or morality; ‘genetic essentialism’; eugenics

• commercialisation –  ‘Big Pharma’

• unlike Europe – Australians have not lost faith in the possibility of effective public regulation

Genetic information un-‘exceptional’?

• Family history has been used for >100 years by doctors, insurers

• Other predictive tests (cholesterol, sugars)

• Other medical tests/info also very sensitive (eg Hep B/C, HIV-AIDS, STDs, cancers)

Artificial and unfair to separate ‘genetic’ and ‘non-genetic’ health information for policy-making purposes

On the other hand, special features …

• Ubiquitous

• Stable – dinosaurs, disasters

• Powerful – tiny sample can tell all

• Powerful – culturally (imagination)

• Familial dimension

• Predictive – but complex! (requires ethical and intelligent use)

• Dynamic technology

Privacy – legal basics

• No common law (or constitutional) right to privacy – statutory protections only

• Complex web of federal and state laws, general and health privacy

• Paradigm - individual autonomy; data

• Privacy Act (Cth) now covers private sector health (including genetic) info

• Privacy Act: coverage does NOT mean prohibition on use, re-use

DP 66 reform proposals

• Extend Privacy Act beyond data to cover identifiable genetic samples (from which information may be derived)

• Amend Privacy Act to allow health professionals to disclose information where a patient’s genetic relative would otherwise be at serious risk of harm

• Extend Public Interest Determinations (beyond doctors) to allow genetic registers etc to collect family medical histories

Genetic databases

• No Oz equivalent of Iceland (DeCODE); UK (BioBank) Estonia; (but Autogen’s private bid).

• ‘Inchoate’ databases — Guthrie Cards, pathology labs, blood banks, tissue banks, familial cancer registers &c

• Large numbers of individual research projects (universities etc)

Genetic databases /2

• Possible responses?
  o National Statement – new chapter?
  o better oversight by HRECs
  o better consent, disclosure protocols
  o de-identification / ‘gene trustees’
  o balancing privacy vs ‘linkage’
  o epidemiology, clinical, research purposes
  o formal licensing/registration?

Other key DP proposals

• Amend Disability Discrimination Act (Cth) expressly to cover unlawful discrimination based on (real/perceived) genetic status

• New criminal offence? 
  o     knowingly/recklessly submitting another person’s genetic material for testing without consent or other lawful authority (eg stat authority, court order)

A Human Genetics Commission?

Widespread support, emphasising:

• Pace of sci/tech change - need for on-going, high level, independent advice to governments/ regulators/ industry/ community

• Broad-based membership (technical/ELSI, expert/community, States)

• Specific responsibilities:
  o Insurance, employment, education, identification of ‘sensitive’ tests
  o Not to overlap with the NHMRC

Medical research – emerging issues

• consent for re-use/unspecified future uses

• autonomy, skills (licensing?) of HRECs

• waivers of consent by HRECs

• extended duties of care?

• privacy laws versus ‘linkage’ (specific research, broad epidemiology)

• commercialisation and conflicts

• multiple partners (esp transnational)