Emeritus Professor David Weisbrot AM - University of Sydney - Removing or dealing with the legal...

ELSI inhibitions to expanding

genomic healthcare services: privacy,

discrimination, ethics and patenting

Emeritus Prof David Weisbrot AM

Genomics in Healthcare @ Garvan – 13 Nov 2014

Human Genome Project

• 26 June 2000 –Decoding the Book of

Life: Clinton & Blair

announce the first

complete sequencing of

the human genome, int’l

consortium led by Francis

Collins (NHGRI) and

Craig Venter (Celera):

total cost US$ 3.2B, 5%

set aside to explore ELSI

DW - Genomics in Healthcare - Garvan Institute - 13 Nov 2014 2


ALRC-NHMRC inquiry

Aug 2000, Govt announces ALRC-NHMRC joint inquiry:

In relation to human genetic information – and the samples from which this is derived – how can we best:

• protect privacy interests

• protect against unfair discrimination

• ensure the highest ethical standards


Application to many contexts

• Medical/scientific research

• Clinical genetics

• Systemic health care issues

• Human genetic databases (‘biobanks’), tissue banks, registers

• Employment

• Insurance

• Kinship and Identity (immigration, parentage, ethnicity /Aboriginality)

• Other right, services (eg education, aged care, sports)

• Forensics


Final Report – ‘ALRC 96’

• 144 recommendations: >90% accepted

• Directed at 31 bodies (govts; regulators; educators; health professionals; insurers; employers; police etc)

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


Social ambivalence about genetics

Optimism about medical breakthroughs

• in diagnosis, treatment, prevention (gene therapy, ‘smart drugs’) of genetic diseases

– affected families are especially positive and passionate

Anxiety about loss of control

• ‘mad science’, eugenics, ‘genetic essentialism’

• commercialisation (Big Pharma = ‘Evil Empire’?)

• intensify gap between haves and have-nots?

• loss of faith in capacity to regulate biotech?

7DW - Genomics in Healthcare - Garvan Institute - 13 Nov 2014


GATTACA


Addressing community concerns

Strong spirit of altruism for genetic research, BUT must address the associated (legitimate) concerns, or risk backlash:

• Research/biobank governance: independence, openness & accountability, ethical oversight

• Preventing collateral damage: genetic privacy and discrimination

• Access and equity: affordability/access, benefit sharing, commercialisation

Whole Genome Sequencing

• The first fully sequenced human genome

cost $3.2B (in 2000)

• Now the cost of sequencing is plummeting

with Next Gen machines (@ the Garvan)

• The cost of fully interpreting the data is still

very high, but will fall with advances in

bioinformatics.

• What new and different ethical, legal and

social implications arise??



The regulatory approach

Use a sophisticated mix of strategies:• constant oversight through HGAC (NHMRC)

• amend legislation and regulations

• official standards and codes of practice– eg NHMRC and Privacy Commissioner’s offical

Guidelines, laboratory accreditation standards

• industry codes and best practice standards– insurance industry’s policy on genetic testing

• education and training (specialist & community)

• peer review

• funding incentives/disincentives

• better coordination of governmental programs


Systemic healthcare issues

• Ready the healthcare system now for when

‘all medicine will be genetic medicine’

• Prepare family doctors to be the key

advisers, gatekeepers– criticisms about knowledge, communication skills

– need integrated programs from med schools CME

– Need intensified by DTC genetic services?

• More resources/support for (cost-effective)

genetic counsellors and support groups


Addressing genetic privacy

A real fear of exposure

– threatens good decision-making by patients and altruistic feelings towards research

• Strong protection of sensitive health info

– regulation of e-health records, databases

– concerns re transborder data flows (APEC?)

– cover identifiable samples (beyond ‘data’)

• But must sensibly accommodate

– the critical family dimension (access, disclosure)

– epidemiological, health planning work

– emergencies, and the desire for convenience

– amended legislation, NHMRC guidelines

DW - Genomics in Healthcare - Garvan Institute - 13 Nov 201414

Punish non-consensual testing?

Decreased cost, increased availability, $$ incentives encourage illicit testing eg by parents, employers, insurers, investigators, and ...

ALRC R12-1: need a new criminal offence for non-consenual DNA testing, absent other lawful authority (eg court order, statutory, ethics-approved research)

Nov 2008: SCAG/MCOCC released a DP with 4 model offences; subs closed on 31 January 2009 [still waiting ...]

UK Human Tissue Act 2008 s 45 codifies this offence

10 US states, Germany (April 2009)


Employment/HR context

• Few industrial disputes yet – but incentives for

genetic testing/screening

– direct economic incentives (reduce insurance & WC

premiums, sick leave, staff turnover)

– OH&S duties; public health and safety

• We can anticipate increased pressure for genetic

testing as cost decreases, access increases

– Cf increasingly widespread drug and alcohol testing,

‘psychometric’ testing, workplace surveillance


Some actual workplace scenarios

• Burlington Ry case – (surreptitious/dishonest) testing

of labourers for ‘predisposition to RSI’

• Norman-Bloodsaw v Lawrence Berkeley Lab (1998) –

singled out black female employees for gen-testing

• Victorian Boxing Council – require testing for prof’l

boxing licences (‘punch drunk syndrome’)?

• Pilots – US, UK airforces (re sickle cell carriers)

• Basketball, AFL: Marfan syndrome, heart conditions &c

• ID testing: Police (Vic/Tas/AFP) – to distinguish their

DNA from that found at crime scene samples;

17

Employment – ALRC approach

• 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 predisposition

• Justifies a more interventionist approach:

– General rule: no use of predictive genetic testing or

genetic information in the workplace …

• rare/exceptional cases where necessary to discharge OH&S or

public safety obligations (eg beryllium mine) and

• the test/interpretation has been expressly approved for this

purpose by the HGCA and NOHSC

DW - Genomics in Healthcare - Garvan Institute - 13 Nov 2014

DDA amendments 2009

The Disability Discrimination and Other Human

Rights Legislation Amendment Act 2009* (Cth):

• Amends the definitions of ‘disability’ in DDA s 4(1)(j) &

the Workplace Relations Act to clarify that the legislation

applies to discrimination based on genetic status – including

a genetic predisposition to a disability √ (per ALRC R9-3 & Prod’yComm)

• Prohibits an employer from requesting or requiring

information, including genetic information, from a job

applicant or employee, except where this information is

reasonably required for purposes that do not involve

unlawful discrimination √ (per ALRC R31-3)

* (These provisions in force since 5 August 2009)


Genetic Discrimination ProjectFindings re Employment (August 2008)

• “No evidence of systematic use of genetic testing or other genetic

information by Australian employers for screening or monitoring

purposes. It did, however, find some evidence, albeit low incidence, of

the use of genetic information by way of family history for pre-

employment health screening (24) and monitoring employees (15).”

• “However, … in spite of the apparently low frequency of incidents of

genetic discrimination in the Australian workplace context, where

incidents were reported, they were serious in nature and had

significant impact and far-reaching implications for respondents

and their families. This reaffirms the significance for individuals of

gaining and maintaining access to employment with its associated

opportunities and benefits including financial security, self esteem,

productivity and opportunity for community engagement and social

participation.”


GINA 2008 (US)Genetic Information Nondiscrimination Act 2008 – passed

overwhelmingly in the US Congress (99-0 in Senate)

– Signed by President Bush (as he had done as Gov of Texas);

>40 states regulate use of GI in employment: some ban collection

and use; others only ban discriminatory use.

– Employment provisions (Title II) take effect on 21 Nov 2009

• Prohibits companies* based in the US from asking an

employee, a potential employee or a family member of an

employee for a sample of their DNA.

• Prohibits employers* from using genetic information for

hiring, firing, or promotion decisions, and for any decisions

regarding terms of employment.

* Does NOT apply to companies/employers with fewer than 15 employees



Insurance Underwriting

• Disclosure requirements and individual risk-

rating (eg life insurance, income protection)family medical history or genetic test?

cf community-rated insurance: private health

concerns about adverse selection if GI exempted

• FSA policy on genetic testing (ACCC authorised)

• ALRC focus: (1) assure scientific reliability and

actuarial relevance; (2) provide reasons; (3)

provide review mechanism (besides courts);

(4) industry education

DW - Genomics in Healthcare -

Garvan Institute - 13 Nov 2014

Regulating ‘Dermagenetics’?

22



Nutrigenomics?

23



23andMe:

‘genetics just got personal’

24

Potential (formal) regulators?

• ACCC – for false and misleading conduct

• Therapeutic Goods Administration (TGA)– Regulation of therapeutic goods in Australia to ensure

quality, safety & efficacy of medicines/medical devices.

– Uses ‘risk management approach designed to ensure public

health and safety, while at the same time freeing industry

from any unnecessary regulatory burden’.

– TGA (very quietly) announced new regulatory framework

on 1 July 2010: Human genetic testing Class 3 IVD:

‘moderate public health risk or high individual risk’,

including possible stress and anxiety relating to the

information and/or follow-up measures



ALRC 99: Genes & Ingenuity

• ToR: 17 Dec 2002

• 700 pp report completed June 2004; tabled in Parliament Aug 2004

• 50 recommendations

• Influential overseas (AAAS, OECD, UNESCO)

• Gov’t response finally in Nov 2011 – after many false alarms, a separate Senate Inquiry 2010 and private member’s bills

Impetus for ALRC inquiry: Myriad/BRCA

• 1994 discovery 9 patents on BRCA1/BRCA2 (sequences and methods) for Utah U and its biotech spin-off Myriad Genetics

• Unusually aggressive enforcement practices:

– (a) insistence on monopoly testing in Salt Lake City lab;

– (b) fast, high quality, but fears monopoly would cost increases (as in Canada: 2-3X increases); and

– (c) legal threats for non-compliance

• Provoked widespread non-compliance, denunciation and/or litigation internationally (see below) – media attention and public controversies in the US, Canada, France, Australia and New Zealand


GTG and BRCA: A&NZ

• 2002: GTG gets ‘exclusive cross-license’ for BRCA1 in

A&NZ from Myriad (for GTG’s 1993 ‘junk DNA’ patent)

• 2003: during ALRC inquiry, GTG announces ‘gift to

the Australian people’

• 11 July 2008: new management announces it will

enforce its BRCA testing rights in A&NZ (from 6 Nov)-- Oct 2008: ACCC reported to be investigating (didn’t confirm or deny)

• 24 Nov 2008: ‘decision under review’ by new Board

• 2 Dec 2008: Board resolves ‘to immediately revert to

its original decision to allow other laboratories in

Australia to freely perform BRCA testing’


SCOTUS rules (13 June 2013)

• Naturally occurring genes/DNA segments not patentable

opens up more contestable market for diagnostic testing? (Writs

already flying!)

didn’t deal with WGS, but presumably testers won’t have to navigate

the ‘patent thicket’?

Our ageing (patent) society: the early gene patents expiring soon in

any event (eg Myriad’s BRCA patents in 2016)

application beyond ‘human genes’, of course

Will this open up Myriad’s proprietary database of BRCA testing

experience?

• Synthetic or edited forms of genes not found in nature

(complementary DNA, or cDNA) may be patented –

not especially useful for diagnostics – but more so for therapies,

pharmaceuticals


Full Federal Ct of Australia• In Cancer Voices Australia v Myriad Genetics (5 Sept 2014),

unanimously upheld Myriad’s BRCA1 patent, finding the isolated

nucleic acids “are different to the gene comprising the nucleic acid

sequence as it exists in nature”; and that the chemical changes in the

isolated nucleic acid distinguished the product as both artificial and

economically useful.

• Why different from the SCOTUS? FCA: (1) US law expressly

excludes ‘products of nature’ from patentability, but this wording is

not in the Australian law; and (2) SCOTUS failed to account properly

for the differences between the DNA sequence found in the body and

the isolated DNA sequence, which “is not a product of nature”.

• FCA: this is a legal ruling on the words of the statute; Parliament can

amend the IP law to reflect ethical and social concerns if it wishes.

• Cancer Voices announced intention to seek leave to appeal to the

High Court of Australia.


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Emeritus Professor David Weisbrot AM - University of Sydney - Removing or dealing with the legal...

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