Dianne Nicol - University of Tasmania - Should we be worried about direct to consumer genetic...

Should we be worried about direct to consumer genetic

testing?

Professor Dianne Nicol

Centre for Law and Genetics

Law Faculty

University of Tasmania

Nicol - National Pathology Forum 2013

1

Policy and academic debates on health-related genetic testing

• Efficacy and accuracy

o False negatives and positives

• Understanding test results

o Diagnosis and susceptibility

• Individual well being

o The right to know and not to know

o Incidental findings

• Family

o Confidentiality and duty to disclose

• Third parties

o Privacy and discrimination

2 Nicol - National Pathology Forum 2013

Commercialisation of testing services

• Pharma blockbuster drugs

• Most tests not on MBS

• Fee for service

• Selling test kits

• Using patent rights

o Most controversial

o BRCA example

• The new direct to consumer (DTC) genetic testing business model


DTC testing

• Outside traditional clinical paradigm

• Direct advertising, GP mediated delivery

• Direct advertising, delivery using collection kits, results (e.g. 23andme)

• No Australian DTC companies in 2003

• 2012 - 16 DTC companies operating in Australia

o 5 GP mediated

o 4 medical (e.g. Lumigenix)

o 7 other (paternity, ancestry, etc)



5

Concerns about DTC testing

• Efficacy - variable results from different DTC companies

• Understanding results, potential for harm, pressure on health care system to interpret

• De-medicalisation, lack of counseling

• Conflict of interest - using samples for commercial research purposes, patenting

• Consent – non consensual, children

• Privacy in the commercial environment


Survey of public concerns

• Nationwide computer assisted telephone survey – two groups – GP provider and company provider

• Examined reasons for differences in trust across providers, including regulation, clinical validity, privacy and expertise.


7


8 0.0 0.5 1.0 1.5 2.0 2.5 3.0 3.5 4.0 4.5 5.0

The accuracy of the genetic analysis

The accuracy of the report s findings

The level of genetic expertise of staff*

That the report conformed to Australian ethical guidelines

That the report conformed to Australian scientific standards

Would provide you with genetic counselling

Would provide you with expert genetic or medical advice if needed

Would keep your genetic information private

Would not contact you in the future and attempt to sell you medication, drugs orother health care services

Would not use your genetic results without your permission

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Company GP

How good are DTC companies at protecting privacy?

• Studies in Canada and Australia

• Both countries have a co-regulatory approach

o Incorporation of privacy principles in privacy policies

• Examination of online DTC company privacy policies

o Most fail to include Australian National Privacy Principles and their Canadian equivalents


9

Regulation of genetic testing in Australia

• Very complex

• But gaps – particularly DTC tests

• A ‘regulatory nightmare’

• What is regulated?

o Test providers

o Manufacture and supply of tests

o Marketing and advertising

o Delivery of testing


Regulation of manufacture and supply

• New component in regime for registration of

therapeutic goods

• Genetic tests are in vitro devices (IVDs), a

subset of medical devices

o Covers test kits, at home testing and in house

testing

• Requirements don’t apply for products not

supplied in Australia



12

Key features of regulation of IVDs

• Commercial and in house use both covered

• Must conform to essential principles regarding quality, safety and performance

• Must be included on the ARTG

• Level of regulation commensurate with risk: four classes from low public health and personal risk through to high public health risk

• Genetic testing is class 3

In house tests

• Developed in lab context – not supplied commercially

• Post July 2014 - for classes 1-3:

o Must notify TGA of all types of tests

o Must be NATA accredited

o Must comply with NPAAC standards

• Applies to DTC provides in Australia as well as clinics


Home use tests

• Self-testing at home or in similar environment not under supervision of health care provider

• Some home use tests are prohibited (only if used exclusively for that purpose)

o testing for pathogens or transmissible agents

o genetic testing for the presence of or susceptibility to diseases

o testing for serious disorders, eg cancer, myocardial infarction

o testing for markers that are precursors to a serious disease or condition


Foreign DTC testing companies

• TGA does not have jurisdiction over foreign companies operating overseas

• Can’t stop people from using services of

23andme etc

• Can stop import and export – does this include import of collection kits?

o Exempt where not intended for commercial supply

• In France it is an offence for individuals to contract for DTC services


15

Regulation of testing and its consequences

• Legally enforceable obligations:

o Obtain consent

o Protect privacy and confidentiality

o Avoid unlawful discrimination

• Other best practice considerations:

o Referral from health care professional

o Non-directional genetic counseling

• Enforceability outside of Australia?


Privacy issues

• Genetic test information

o Is it special? - arguably yes, but note ‘genetic exceptionalism’

o ALRC/AHEC rejected specific protection for genetic privacy

• Privacy protection for genetic test information

o Until recently no distinct status

o Now specifically defined within ‘health information’ or other ‘sensitive’ information in Privacy Act


Protection of genetic samples

ALRC/AHEC recommendations

• Protect genetic samples as the source of genetic information by treating samples as information under federal privacy legislation (not accepted)

• Create a new criminal offence in respect of non-consensual genetic testing (accepted but not yet implemented)


New privacy requirements in March 2014

• APPs replace NPPs and IPPs

• More detailed requirements for privacy policies - clear and easily accessible to consumers

• Commissioner empowered to conduct an assessment of compliance

• DTC companies will need to improve their privacy policies


19

Considerations for the future

• Internationally coordinated approach –

o Consumer protection

o Best practice principles

• Industry codes of practice

• Consumer and health professional education

• More genetic counselors

• The role of law: prohibit or regulate?


M

DTC Testing

Commercial Advertising

Media

Non-Commercial

Family/Friends Healthcare related Healthcare

System

DTC Testing

DTC Research

DTC Sequencing

DTC Sharing,

Interpreting

Commercial Advertising

Media Referrals

Non-Commercial

Family/Friends Healthcare related Healthcare

System

Date post:	28-Nov-2014
Category:	Health & Medicine
Upload:	informa-australia
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Dianne Nicol - University of Tasmania - Should we be worried about direct to consumer genetic...

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