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EXPLANATORY MEMORANDUM
(Circulated by authority of Senator Stott Despoja)
Genetic Privacy and Non-discrimination Bill 1998
Outline
The Genetic Privacy and Non-discrimination Bill 1998 (the Bill) protects the genetic privacy
of individuals and makes genetic discrimination unlawful. The Bill also defines the
circumstances in which genetic information and DNA samples may be collected, stored,
analysed, and disclosed, the rights of individuals and persons with respect to genetic
information, the responsibilities of persons with respect to genetic information, and the
unlawfulness of genetic discrimination against individuals and families. It establishes
effective mechanisms to enforce these rights and responsibilities.
Financial Impact
Unknown as there are no figures available which show the financial impact of protecting
genetic privacy and preventing genetic discrimination.
Notes on Clauses
Part 1 - PRELIMINARY
Clauses 1 and 2
These clauses set out the short title and commencement of the Bill. The Bill is to commence
on a day to be fixed by Proclamation.
Clause 3
This clause sets out the intention that this Bill will not affect the operation of a law of a State
or of a Territory that is capable of operating concurrently with this Bill.
Clause 4
This clause provides that the Bill binds the Crown but does not make the Crown liable to be
prosecuted for an offence.
Clause 5
This clause extends the Bill to all external Territories.
Clause 6
This clause sets out the objects of the Bill.
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Clause 7
This clause sets out the definition of specific words used in the Bill.
PART 2 - DISCLOSURE OF GENETIC INFORMATION TO THIRD
PERSONS
Clause 8
This clause sets out the circumstances in which genetic information about an individual may
be disclosed. Genetic information may only be disclosed if:
· the individual has authorised the disclosure;
· the disclosure is required or authorised by or under law; or
· the person believes on reasonable grounds that the disclosure is necessary to prevent
or lessen a serious and imminent threat to the life or health of the individual or of
another person.
This clause restricts the re-disclosure of genetic information only to the extent reasonable in
the exercise of judgment for professional medical consultation, for the direct benefit of a
patient or with the written authorisation of the individual.
Clause 9
This clause sets out the criteria that must be satisfied for there to be a valid authorisation to
disclose genetic information and the limits of that authorisation.
Clause 10
This clause sets out the mechanism for the inspection and copying of genetic records. A
genetic record can be inspected following a written request and a copy may be provided to
the individual. Where a written request has been received, the record holder has 30 days after
receiving the request to make the information available in non-technical form. There may be
a charge for any copying which must not exceed the administrative and duplication costs.
Clause 11
This clause sets out the mechanism for amending genetic information. This may be done by a
written request to the genetic record holder who has 30 days after receiving the request to
agree or refuse to add the written amendment to the record. If the information is not accurate
or complete for the purpose for which the information may be used or disclosed, the record
must be amended. Where an amendment is made, the individual is to be informed as well as
any other person to whom the information was disclosed.
If the person refuses to make the amendment then reasons for this refusal must be provided
within 30 days, as well as information about any procedures for further review of the refusal
and about the right of the individual to provide the person with a concise, written statement
setting out the requested amendment and the reasons of the individual for disagreeing with
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the refusal of the person to make the amendment. This statement must then form part of the
record and be made available in all subsequent disclosures. A statement of the reasons for not
making the requested amendment may also form part of the record.
PART 3 - COLLECTION, STORAGE AND ANALYSIS OF DNA
SAMPLES
Clauses 12 to 16
These clauses set out the requirements for the collection, storage and analysis of DNA
samples which must be satisfied.
To collect a DNA sample there must be a written authorisation from the individual, specified
information must have been provided to the individual, a specified notice of rights and
assurances must have been provided to the individual and the collection must be in
accordance with the authorisation.
Storage or conducting of a genetic analysis of a DNA sample from an individual may occur
only if the person has the written authorisation of the individual, and notice has been
provided and the person stores or conducts the analysis of the DNA sample according to the
authorisation and notice of rights and assurances.
A notice of rights and assurances must be provided to the individual before the collection,
storage or analysis of a DNA sample and the notice must contain the following information
and assurances:
· the DNA sample will be used according to the written authorisation;
· the individual has the right to order the destruction of an identifiable DNA sample at
any time;
· the DNA sample will be destroyed upon the completion of the genetic analysis or the
genetic test, unless the individual has consented in writing to further use of the sample;
· the individual may specify another person as the person authorised to make decisions
regarding disposition of the DNA sample after the death of the individual, and, if any
person is so designated, that the individual should notify the facility in which the DNA
sample is stored;
· that the individual has the right to examine records containing genetic information, to
obtain copies of such records, and to request amendment of such records;
· that researchers may be granted access to a DNA sample only as specified in the written
authorisation of the individual;
· that the collection, storage, and analysis of the DNA sample and the genetic
information characterised from the sample are protected by this Act, and that an
individual whose rights under this Act are violated may seek redress as provided for in
this Act; and
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· about the availability, or the lack of availability, of optional genetic counselling.
To collect a DNA sample, the following information must be provided to the individual
before the collection and in language understandable to the individual:
· that consent to the collection of the DNA sample is voluntary;
· about the genetic information that can reasonably be expected to be derived from the
genetic analysis;
· about the implications of genetic information derived from the genetic analysis, for the
individual and the family members of the individual;
· about the ways in which the genetic information derived from the genetic analysis will
be used;
· about the information that the individual can expect to receive on completion of the
genetic analysis;
· about the extent of the right of the individual to have the DNA sample removed from a
research study and, if possible, to have the genetic information characterised from the
DNA sample destroyed;
· about the right of the individual to revoke consent to the genetic analysis at any time
prior to the commencement of the genetic analysis;
· that revocation of consent for genetic analysis does not absolve the individual of
responsibility for all relevant costs of the genetic analysis;
· that the genetic analysis may yield information that should be communicated to a
family member of the individual;
· about the existence of, and protections afforded by, this Act; and
· about the availability, or the lack of availability, of optional genetic counselling.
To collect, store or conduct genetic analysis of a DNA sample an authorisation must:
· be in writing, signed by the individual, and dated on the date of the signature;
· identify the person authorised to collect the DNA sample;
· state the tissue to be collected and the method of collection;
· include a description of all authorised uses of the DNA sample;
· indicate whether the individual permits the sample to be retained after the analysis is
completed and, if not, how the sample is to be disposed of after the analysis;
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· include provisions that permit the individual to consent to specify the use of the DNA
sample for research, negotiate commercial use of the DNA sample and the implications
for the individual or family member if the genetic information is used with identifiers;
and
· comply with additional provisions requiring informed consent by human subjects in
research.
The authorisation must be retained for the period during which the DNA sample is collected,
analysed and stored, and a copy of the completed authorisation must be provided to the
individual.
PART 4 - DISCRIMINATION PROHIBITED
Clause 17
This clause makes genetic discrimination unlawful. Genetic discrimination describes the
different treatment of individuals and their family based on genetic differences (presumed or
actual) and may be distinguished from discrimination based on having symptoms of a genetic
disease. In this Bill, genetic discrimination occurs when an act, involving a distinction,
exclusion, restriction or preference, is based on genetic information and has the purpose or
effect of nullifying or impairing the recognition, enjoyment or exercise, on an equal footing,
of any human right or fundamental freedom in the political, economic, social, cultural or any
other field of public life.
Clause 18
This clause makes certain information about an employee or a potential employee available to
the employer to characterise an employee or potential employee. An employer may request or
require or use the genetic information of an employee for the purpose of permitting a
genetically susceptible employee to avoid occupational exposure to substances with a
mutagenic or teratogenic effect, or determining a genotype that is otherwise directly related to
the work and is consistent with business necessity, but an employer shall not request, require,
or use the genetic information of an employee or a prospective employee for any purpose
restricting any right or benefit otherwise due or available to the employee or the prospective
employee.
Clause 19
This clause makes certain information about an individual available to an insurer. An insurer
may request or require or use the genetic information of an individual if the genetic analysis
from genetic information has already been undertaken and a genetic record exists, but an
insurer must not terminate, restrict, limit, refuse to renew, or otherwise apply conditions to
the coverage of an individual or family member under the policy or plan involved, or restrict
the sale of the policy or plan to an individual or family member on the basis of any genetic
information about a healthy individual or a healthy family member, or on the basis of a
request for, or receipt of, genetic services by an individual or family member. Also, an
insurer must not discriminate against an individual's family in the provision of insurance
coverage, or require an applicant for insurance coverage, or an individual or family member
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who is enrolled under an insurance coverage policy or plan, to be subjected to genetic
analysis or to be questioned about genetic information.
PART 5 - RESEARCH
Clause 20
This clause specifies that a DNA sample may be analysed as part of a research project only if
a number of conditions are met. The researcher must determine that use of DNA samples is
essential to the research project and that the potential benefit of the research project to society
outweighs the potential risks to the research subjects (including psychosocial risks and
intrusion into the privacy of the subjects that would result from genetic analysis of DNA
samples). The researcher must determine that the research protocol contains adequate
safeguards to protect against disclosure of genetic information that is generated by the
research, the requirements for the collection of a DNA sample under the Bill have been
satisfied, the intended uses of the DNA samples is described and that authorisation has been
sought for specific molecular genetic genotype information to be included in records. There
are specific requirements if the DNA sample is from a deceased individual prior to the
commencement of this Act. The research protocol must describe the availability, or lack of
availability, of genetic counselling related to the research project.
Adequate safeguards against disclosure of genetic information, at a minimum, include:
· satisfying any guidelines issued by the National Health and Medical Research Council
and approved by the Privacy Commissioner under section 95 of the Privacy Act 1988;
· ensuring that research subjects will not be identifiable in any report or publication that
results from the research without their authorisation; and
· having procedures to remove or destroy any individual identifiers at the earliest
opportunity, consistent with the purposes of the project and the terms of the
authorisation of the subjects involved.
This clause also specifies that a DNA sample collected, stored, or analysed in connection
with a research project must be destroyed on the date of completion of the project or
withdrawal of the subject from the project, whichever occurs first, unless the researcher
obtains a specific authorisation to store the sample after the completion date.
This clause also specifies that if a research project includes genetic analysis of the family
members of a subject for pedigree analysis or linkage analysis, then the genotype records
must be stored in strict confidentiality, the genetic information must be disclosed only in
accordance with the Act and the authorisation must include information about:
· the possibility that family members of the subject may learn genetic information about
the subject as a result of a project;
· the possibility that the project may determine that some family members are not genetic
relatives; and
· the disposition of records and data generated during the project.
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Clause 21
This clause specifies that a person who stores genetic information on a subject may allow
access to such information only with the written authorisation of the subject according to the
provisions of this Act, and such information shall be provided with individual identifiers, or
codes, or no identifiers, according to the written authorisation of the subject. But, a person
who stores genetic information may grant access to such information solely for the purpose of
inspection or review of the records containing the information if:
· the inspection or review is for the purpose of compiling data for statistical or
epidemiological studies and genetic information that contains personal identifiers is not
copied, removed from the records, or redisclosed in any way; and
· the person conducting the inspection or review certifies in writing that the limitations in
paragraph 21(2)(a) will be complied with, that the person has complied with this Act
and that the person has knowledge of liability for breaches of this Act.
Clause 22
This clause specifies that a DNA sample collected prior to the effective date of this Act may
be analysed as part of a research project, unless the individual involved, within 3 years of the
commencement date of this Act, submits a written request that such sample be withdrawn or
destroyed. Genetic information collected as part of a research project described in this
section, may be disclosed only with the authorisation of the individual involved or the
individual's legal representative unless otherwise provided by this Act.
PART 6 - MISCELLANEOUS
Clause 23
This clause specifies that any person in possession of DNA samples and genetic information,
who intends to transfer control of, or discontinue, activities or services related to the analysis
of DNA samples, must inform the individual that the individual has the right to:
· consent to the transfer of the samples or records containing the genetic information;
· order that the samples or records be returned to the individual; or
· order that the samples or records be destroyed.
However, if, within a period of 3 months after notification, the person receives no response
from the individual, the person:
· may destroy the samples or the records if the activities or services are discontinued;
· may place the samples and research records, without personal identifiers, in a tissue
sample archive, according to prior instructions of the individual; or
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· may proceed with the intended transfer of the samples and records.
Clause 24
This clause specifies that where genetic information is available from genetic analysis before
the birth of a person, the genetic information becomes the genetic information of that person
when they are born alive. This means that before a live birth the genetic information is dealt
with by this Act as the mother's information. Following live birth the information becomes
the child's and the mother must seek authorisation to re-disclose the genetic information. This
clause restricts the information that becomes the child's to genetic information derived from
the genome of the child, and does not include genetic information about the mother's genome
or other genomes. The genetic information about the mother's genome does not become the
child's. To maintain the operation of the Act for the use, disclosure, etc. of the child's genetic
information the child is then defined as the 'individual' for the purposes of the Act.
PART 7 - PRIVACY AND DISCRIMINATION COMPLAINTS
Clauses 25 and 26
Clause 25 provides that an individual may complain about an act or practice that may be an
interference with the privacy of the individual according to this Act by making a complaint to
the Privacy Commissioner under section 36 of the Privacy Act 1988. Where a complaint has
been made to the Privacy Commissioner under section 43, Part V of the Privacy Act 1988
(except subsections 41(3)(a), 41(4), 52(3A) and 63(1)) applies as if the complaint under
section 43 was a complaint under section 36 of the Privacy Act 1988.
Clause 26 provides that an individual may complain about an act or practice that may be
genetic discrimination according to this Act by making a complaint to the Human Rights and
Equal Opportunity Commission under section 20 of the Human Rights and Equal
Opportunity Commission Act 1986. Where a complaint has been made to the Human Rights
and Equal Opportunity Commissioner under section 45, Division 3 of Part II of the Human
Rights and Equal Opportunity Commission Act 1986 (except section 29) applies as if the
complaint under section 45 was a complaint under section 20 of the Human Rights and Equal
Opportunity Commission Act 1986.
PART 8 - OTHER BREACHES AND PENALTIES
Clause 27
This clause provides that the breaches and penalty provisions in Part 8 apply only if there is
no complaint mechanism available to the Privacy Commissioner or the Human Rights and
Equal Opportunity Commissioner in Part 7.
This clause provides that any individual whose rights under this Act have been breached may
maintain an action for damages or equitable relief, as provided for in this Part.
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This clause provides that in any action brought under this clause, a court may order:
· a person to comply with the provisions of this Bill; and
· any other appropriate equitable relief.
This clause also provides that any person who negligently collects, stores, or analyses a DNA
sample of an individual in breach of this Act, or negligently induces another person to
conduct such collection, storage, or analysis, shall be liable to the individual for each such
breach in an amount equal to:
· any actual damages sustained as a result of the collection, storage, or analysis, or
$50 000, whichever is greater;
· in any case in which such breach has resulted in profit or monetary gain, treble
damages; and
· in the case of a successful action under this section, the costs of the action and
reasonable costs as determined by the court.
Any person who wilfully collects, stores, or analyses a DNA sample of an individual in
breach of this Act, or wilfully induces another person to conduct such collection, storage, or
analysis, shall be liable to the individual for each such breach in an amount equal to:
· any actual damages sustained as a result of the collection, storage, or analysis, or
$100,000, whichever is greater;
· such punitive damages as the court may allow; and
· in the case of a successful action under this section, the costs of the action as
determined by the court.
SCHEDULE 1 - NOTICE TO ACCOMPANY DISCLOSURES
The following written statement shall accompany each disclosure:
"This information is obtained from the DNA sample of an individual and has been disclosed
to you from confidential records protected under the Genetic Privacy and Non-discrimination
Act 1998. Any further disclosure of the information without specific written authorisation of
the individual is prohibited and is subject to the penalties under the Genetic Privacy and Non-
discrimination Act 1998".
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