Australian Law Reform Commission

Prof David Weisbrot

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

• protect privacy

• protect against unfair discrimination

• ensure highest ethical standards

Application to many different contexts

• Medical research

• Clinical practice

• Systemic health care issues

• Genetic databases, tissue banks, registers

• Employment

• Insurance

• Law enforcement

• Kinship & Identity (immigration; parentage; Aboriginality?)

• Other contexts (eg sport)

Inquiry Processes

• ALRC-AHEC received ToR (Feb 2001)

• Advisory committee (geneticists, doctors, bio-ethicists, insurers, actuaries, lawyers)

• Research – national, international

• Public consultation docs (IP 26, DP 66)

• 15 public forums around Australia

• >200 meetings, consultations

• Written submissions (>300)

Final Report – March 2003

• Essentially Yours: The Protection of Human Genetic Information in Australia (ALRC 96) (launched 29 May)

• 144 recommendations

• Directed at 31 bodies: federal and state governments – health, OH&S, police, privacy, immigration; NHMRC; NATA; TGA and other regulators; IFSA and ICA; employers; educational authorities, etc

Implementation rates

• Substantial Implementation [n37-56%]

• Partial Implementation [n15-23%]

• Nil Implementation [n10-15%]

• Proposals under consideration [n4-6%]

A Human Genetics Commission

• Centerpiece: Recommended establishment of an independent, statutory advisory body: a Human Genetics Commission of Australia (HGCA)

• Recognises rapid change, need for continuing high level advice to government/industry and to maintain public confidence

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

• Specific responsibilities:

• advice to insurers, employers, regulators (eg TGA); promote genetics education; provide national leadership and coordination

Is genetic information special?

• Unique (although 99.9% Ξ !)

• Ubiquitous

• Powerful – one cell tells all

• Stable – dinosaurs to disasters

• Familial dimension

• Predictive – but interactive, contingent and complex!

• Dynamic technology

On the other hand …

• Family history of hereditable diseases has been used for >100 years by researchers, doctors, and insurers

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

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

Employment

• Very few industrial disputes yet (police?) – but employer incentives for genetic screening

• Direct economic incentives (reduce insurance premiums, sick leave, staff turnover)

• OH&S duties;

• public health and safety (eg pilots, drivers)

• So we can anticipate increased pressure for testing as costs decrease, availability increases

• See also drug and alcohol testing, psychometric testing, workplace surveillance

• Clear public policy: everyone has right to work; part of human dignity; even work for the dole

• Fear of the creation of a ‘genetic underclass’ – currently fit and able, but with a predisposition to a genetic disease/disorder

• This justifies an interventionist approach:
  o General rule: no use of predictive genetic testing/information …
  o Except in limited cases where necessary to discharge OH&S or public safety obligations
  o And the test/interpretation has been approved for this purpose by the HGCA and NOHSC

Insurance fundamentals are sound

• Mutual insurance is a voluntary private market,

• It’s not publicly subsidised (cf community-rated health insurance) and it’s not social security

• Risk-rated life insurance is not an essential good (c30% take-up in Australia )

• Risk-rating based upon full disclosure – drawing distinctions among individuals – is central

• Need to preserve equity among pooled insureds

• Real risk of adverse selection – perhaps not on GT alone, in short term, but …

• No arbitrary distinctions according to source of actual or predicted ill-health

• Need robust policies for the long-term, therefore, “no justification at present for departing from fundamental principles of full disclosure and equality of information”; but, still a need for a range of improvements in interests of consumers

1. Oversight by HGCA

• Anti-discrimination law exemptions (sex, disability, age; but not race) must be based upon reasonable actuarial or statistical data

• Insurers currently self-assess the actuarial relevance of genetic information

* * * *

• HGCA to advise on the use of specific  genetic tests for underwriting, and IFSA, ICA to ensure all members conform (R27-2).

• HGCA to keep a watching brief on relevant international initiatives (eg 2-tier approaches)

• • GTI banned in underwriting
    o eg Denmark (test results; but FMH is OK)

• Two-tier systems
  o eg UK , Holland , Sweden
  o below $ threshold, GT results banned; only above threshold can GT results be used;
  o BUT raises many questions:

  • setting $ threshold – link to mortgages?; index?;

  • why privilege genetic information?

2. Use of family medical history

• IFSA policy applies to ‘genetic test information’ but not to family medical history (FMH) – which is much more widely used.

• Long industry use of FMH, but application and interpretation less certain than GT info?

*   *   *   *

• Insurance industry should develop and publish policies on the use of FMH in underwriting (R27-4).

3. Assuring genetic privacy

• Consent forms (including medical authority forms) should provide sufficient information for applicants to make an informed decision about consent to the collection and use of GI (R28-1)

• Applicants should not be asked for ‘bundled consents’ (R28-2)

• Insurers should seek a PID to collect information about genetic relatives (FMHs) (R28-3)

4. Reasons for adverse U/W decisions

• Currently required under s75 ICA , s107 DDA, and IFSA policy – BUT problems of scope and adequacy.

*   *   *   *

• Insurers must inform applicants of statutory right to reasons for adverse decisions (R27-6)

• IFSA to develop mandatory policies on providing clear and meaningful reasons for adverse U/W decisions based on GT information or FMH – explaining the actuarial, statistical /or scientific basis (R27-7)

5. External review

• Review now available through insurer or HREOC – but problems of accessibility, impartiality and formality.

*   *   *   *

• FICS’ jurisdiction should be expanded to review adverse U/W decisions based on GT or FMH (R27-9):
  o in a timely and efficient manner;
  o conducted by suitably qualified individuals;
  o binding on the insurer but not the complainant; and
  o $ cap set to cover the substantial majority of cases. 

6. Industry education

• Industry should review education and training of brokers and agents regarding the collection and use of genetic information in insurance (R27-10).

• NFITAB, in association with the industry, to review competency standards and the Financial Services Training Package, to incorporate appropriate competency standards regarding the collection and use of genetic information (R27-11)

For further information

• ALRC 96 is available free online at: www.alrc.gov.au

• To purchase in hard copy or CD format, or for further information –