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This is a Bill, not an Act. For current law, see the Acts databases.
750
1996-97-98
The Parliament of
the
Commonwealth of
Australia
THE
SENATE
Presented and read a first
time
Genetic Privacy
and Non-discrimination Bill 1998
No. ,
1998
(Senator Stott
Despoja)
A Bill for an Act to protect the
genetic privacy of individuals, to prohibit genetic discrimination and to
provide for the collection, storage and analysis of DNA samples, and for related
purposes
ISBN: 0644
517417
Contents
A Bill for an Act to protect the genetic privacy of
individuals, to prohibit genetic discrimination and to provide for the
collection, storage and analysis of DNA samples, and for related
purposes
The Parliament of Australia enacts:
This Act may be cited as the Genetic Privacy and Non-discrimination
Act 1998.
This Act commences on a day to be fixed by Proclamation.
It is the intention of the Parliament that this Act is not to affect the
operation of a law of a State or of a Territory that is capable of operating
concurrently with this Act.
(1) This Act binds the Crown in right of the Commonwealth, of each of the
States, of the Australian Capital Territory, of the Northern Territory and of
Norfolk Island.
(2) This Act does not make the Crown liable to be prosecuted for an
offence.
This Act extends to every external Territory.
The objects of this Act are:
(a) to define the circumstances under which:
(i) genetic information may be collected, stored, analysed, and disclosed;
and
(ii) DNA samples may be collected, stored, and analysed;
(b) to define the rights of individuals and persons with respect to
genetic information;
(c) to define the responsibilities of persons with respect to genetic
information;
(d) to protect individuals and families from genetic
discrimination;
(e) to establish uniform rules that protect individual genetic privacy;
and
(f) to establish effective mechanisms to enforce the rights and
responsibilities established under this Act.
In this Act, unless the contrary intention appears:
collect means to obtain a DNA sample.
Convention means any international agreement to which
Australia is a party or has signified agreement.
disclose, when used with respect to the genetic information
of an individual, means to convey, or provide access to, the genetic information
to a person other than the individual.
DNA means deoxyribonucleic acid, which is a genetic material
that is composed of nucleotides, that encode genetic information.
DNA sample includes:
(a) a human tissue sample from which DNA is intended to be extracted;
or
(b) DNA extracted from such tissue sample and other molecules (such as
ribonucleic acids and polypeptides) from which DNA may be derived;
but does not include a tissue sample that is taken:
(c) as a biopsy or an autopsy specimen, or as a clinical specimen solely
for the purpose of conducting an immediate clinical or diagnostic test that is
not a DNA test; or
(d) as a blood sample solely for the purpose of storage in and
distribution by a blood bank.
family means the biological and legal relatives of an
individual who may have a material interest in the genetic information of the
individual.
genetic analysis means the process of characterising genetic
information from a DNA sample.
genetic information means:
(a) information from a DNA sample about genotype; or
(b) information from mutation analysis; or
(c) information about nucleotide and polypeptide sequence(s); or
(d) information about gene(s) or gene products.
genetic record means information (including information
forming part of a database), whether compiled lawfully or unlawfully, and
whether recorded in a material form or not, that records genetic information of
an individual in a manner connecting it with the person's identity.
genetic services means any service providing genetic
analysis.
individual means the source of a human tissue sample from
which DNA is extracted or genetic information is characterised. The term
includes a subject of genetic research and, where appropriate, includes the
parent, guardian or legal representative of the individual.
individual identifier means any information by which the
identity of the individual can be ascertained, but does not include codes that
cannot be used singly to identify an individual.
insurer means an insurer within the meaning of paragraph
51(xiv) of the Constitution.
person includes a family, corporation, partnership,
association, joint venture, a body (whether incorporated or not) established for
a public purpose by or under a law of the Commonwealth, and any other legal or
commercial entity. The term person, used with respect to a human
tissue sample, does not include the individual who is the source of the tissue
sample.
research means scientific investigation that includes
systematic development and testing of hypotheses for the purpose of increasing
knowledge.
researcher means a person who conducts research.
retain means to store a DNA sample or genetic information
characterised from such a sample for an extended period of time after the
initial genetic analysis.
subject, when used with respect to genetic research, means
the source of a human tissue sample collected for genetic
analysis.
(1) A person may disclose genetic information in a genetic record
characterised from the DNA sample of an individual only if:
(a) the individual has authorised the disclosure; or
(b) the disclosure is required or authorised by or under law; or
(c) 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.
(2) The person to whom genetic information has been disclosed may
re-disclose the 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.
(1) To be valid, the authorisation by an individual must comply with each
of the following:
(a) the authorisation must be in writing, signed by the individual, and
dated on the day of signature; and
(b) the authorisation must identify the person authorised to make the
disclosure; and
(c) the authorisation must describe the specific genetic information to be
disclosed; and
(d) the authorisation must identify the person to whom the genetic
information is to be disclosed; and
(e) the authorisation must describe the purpose for which the disclosure
is being made; and
(f) the authorisation must state the date upon which the authorisation
will expire; and
(g) the authorisation must include a statement that the authorisation for
disclosure of genetic information may be revoked or amended at any time prior to
the disclosure.
(2) A copy of the authorisation is to be provided to the individual and a
copy of the authorisation retained with the genetic record.
(3) An individual may revoke or amend the authorisation at any time before
the disclosure. The revocation or amendment must be in writing and addressed to
the person who stores the genetic information.
(4) Each disclosure made pursuant to the authorisation must be accompanied
by the statements set out in Schedule 1.
(5) A general authorisation for the release of records or medical
information is not to be construed as an authorisation for disclosure of genetic
information. With respect to records that contain genetic information, the
requirements for disclosure of genetic information that are described in this
section are to be fulfilled prior to disclosure of the information.
(1) A person who retains the genetic information of an individual in
genetic records must, on written request, permit the individual to inspect the
genetic records containing the genetic information and may provide a copy of any
such records to the individual.
(2) A person described in subsection (1) who receives a written request
from an individual to inspect or copy genetic records must, not later than 30
days after receiving the request, make the information available to the
individual. The person may make the information available by permitting the
individual to inspect the genetic records during business hours, or by
delivering a copy of the genetic records to the individual.
(3) A person must provide a non-technical explanation of terms, and any
codes or abbreviations, used in the genetic records of the individual requesting
the genetic records.
(4) The person may charge an individual (except an individual who
participates as a subject in a research project) a reasonable fee, for copies of
genetic records that are provided under section 16. The fee must not exceed the
actual duplication costs, including administrative costs, to the person
providing the copies.
(1) Not later than 30 days after receiving a written request by an
individual to amend any genetic records, a person who retains the genetic
information in the records must either agree or refuse to add the written
amendment to the record. The person must make the amendment if such information
is not accurate or complete for the purposes for which such information may be
used or disclosed by the person.
(2) If the person retaining the information agrees to make an amendment
under subsection (1), the person must, not later than 30 days after such
receipt:
(a) make the amendment requested;
(b) inform the individual that the amendment has been made; and
(c) make reasonable efforts to inform any other person to whom the
information was previously disclosed of the amendment.
(3) If the person retaining the information refuses to make an amendment
under subsection (1), not later than 30 days after such receipt, the person must
inform the individual in writing of:
(a) the reasons for the refusal of the person to make the amendment;
and
(b) the procedures for further review of the refusal; and
(c) 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 the refusal of the person to make the
amendment.
(4) After an individual has provided a statement of disagreement under
paragraph (3)(c), the person storing the records:
(a) must make the statement part of the records of the individual;
and
(b) in any subsequent disclosure of the disputed portion of the genetic
information, shall include a copy of the statement and may include a statement
of the reasons for not making the requested amendment.
(1) Except as otherwise provided by law, a person may collect a DNA sample
from an individual for genetic analysis, only if the person:
(a) obtains the written authorisation of the individual in accordance with
section 16;
(b) provides the information to the individual in accordance with section
15;
(c) provides the notice of rights and assurances in accordance with
section 14; and
(d) collects the sample in accordance with the authorisation and
notice.
Except as otherwise required by law, a person may store or conduct a
genetic analysis of a DNA sample from an individual, only if the
person:
(a) has the written authorisation of the individual and notice has been
provided; and
(b) stores or conducts the analysis of the DNA sample in accordance with
the authorisation and notice of rights and assurances.
The person who collects the DNA sample for genetic analysis must provide
the individual, prior to the collection of the DNA sample, and any other person
upon request, with a written notice of rights and assurances that contains the
following information and assurances:
(a) that the DNA sample will be used only as authorised in the written
authorisation; and
(b) that the individual has the right to order the destruction of an
identifiable DNA sample at any time; and
(c) that 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; and
(d) that 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;
and
(e) 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; and
(f) that researchers may be granted access to a DNA sample only as
specified in the written authorisation of the individual; and
(g) 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
(h) about the availability, or the lack of availability, of optional
genetic counselling.
Prior to the collection of a DNA sample from an individual for genetic
analysis, the person who collects the sample must inform the individual, in
language understandable to the individual:
(a) that consent to the collection of the DNA sample is voluntary;
and
(b) about the genetic information that can reasonably be expected to be
derived from the genetic analysis; and
(c) about the implications of genetic information derived from the genetic
analysis, for the individual and the family members of the individual;
and
(d) about the ways in which the genetic information derived from the
genetic analysis will be used; and
(e) about the information that the individual can expect to receive on
completion of the genetic analysis; and
(f) 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; and
(g) about the right of the individual to revoke consent to the genetic
analysis at any time prior to the commencement of the genetic analysis;
and
(h) that revocation of consent for genetic analysis does not absolve the
individual of responsibility for all relevant costs of the genetic analysis;
and
(i) that the genetic analysis may yield information that should be
communicated to a family member of the individual; and
(j) about the existence of, and protections afforded by, this Act;
and
(k) about the availability, or the lack of availability, of optional
genetic counselling.
(1) To be valid, the authorisation by an individual must comply with each
of the following:
(a) the authorisation must be in writing, signed by the individual, and
dated on the day of signature; and
(b) the authorisation must identify the person authorised to collect the
DNA sample; and
(c) the authorisation must state the tissue to be collected and the method
of collection; and
(d) the authorisation must include a description of all authorised uses of
the DNA sample; and
(e) the authorisation must 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; and
(f) the authorisation must include provisions that permit the individual
to consent to:
(i) use of the DNA sample for research; and
(ii) commercial use of the DNA sample, with a waiver of, or a provision
for, economic benefit to the individual; and
(iii) if the individual consents to use under subparagraph (i) or (ii),
use without identifiers, or use with individual identifiers or codes retained,
of the DNA sample; and
(iv) notification, if individual identifiers or codes are retained, about
information resulting from such use that may have implications for the
individual or a family member of the individual; and
(g) the authorisation must comply with additional provisions requiring
informed consent by human subjects in research.
(2) The authorisation must be retained for the period during which the DNA
sample is collected, analysed and stored.
(3) A copy of the completed authorisation must be provided to the
individual.
(1) It is unlawful for a person to do any act involving a distinction,
exclusion, restriction or preference based on genetic information which 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.
(2) The reference in subsection (1) to a human right or fundamental
freedom in the political, economic, social, cultural or any other field of
public life includes a reference to any right of a kind referred to in a
Convention.
(3) Subsection (1) does not apply in respect of the employment and
insurance of persons, except as provided in this Part.
(4) The succeeding provisions of this Part do not limit the generality of
subsection (1).
An employer may request or require or use the genetic information of an
employee for the purpose of:
(a) permitting a genetically susceptible employee to avoid occupational
exposure to substances with a mutagenic or teratogenic effect; or
(b) determining a genotype that is otherwise directly related to the work
and is consistent with business necessity;
but, an employer must 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.
An insurer may request or require or use the genetic information of an
individual if the genetic information from a genetic analysis has already been
undertaken and a genetic record exists, but an insurer must not:
(a) 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;
(b) discriminate against an individual's family in the provision of
insurance coverage; or
(c) require an applicant for insurance coverage, or an individual or
family member who is enrolled under an insurance coverage policy or plan, to be
subjected to genetic analysis or to be questioned about genetic
information.
(1) A DNA sample may be analysed as part of a research project only if the
researcher has determined that:
(a) use of DNA samples is essential to the research project; and
(b) 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; and
(c) the research protocol:
(i) contains adequate safeguards to protect against disclosure of genetic
information that is generated by the research; and
(ii) satisfies the requirements of section 12; and
(iii) describes the intended uses of the DNA samples; and
(iv) prohibits inclusion of specific molecular genetic genotype
information in records unless the subjects authorise such inclusion in writing;
and
(v) with respect to protocols involving the use of DNA samples from
subjects deceased prior to the commencement of this Act:
(A) provides a reasonable method for disclosing to the family members of a
subject, the risks that are associated with genetic information of the subject
that is generated by the research, and in reasonable medical judgment, can be
effectively ameliorated, prevented, or treated; and
(B) takes into account the right of family members to refuse to be
informed about the genetic information; and
(vi) describes the availability, or lack of availability, of genetic
counselling related to the research project.
(2) For purposes of subparagraph 1(c)(i), adequate safeguards against
disclosure of genetic information, at a minimum, include:
(a) 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; and
(b) ensuring that research subjects will not be identifiable in any report
or publication that results from the research without their authorisation;
and
(c) 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.
(3) If the DNA sample of a subject is collected, stored, or analysed in
connection with a research project, the researcher must ensure the destruction
of the DNA sample 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 of the subject according to the provisions of this Act,
to store the sample after such date.
(4) If a research project includes genetic analysis of the family members
of a subject for pedigree analysis or linkage analysis:
(a) the genotype records must be stored in strict confidentiality;
and
(b) the process for obtaining the authorisation of the subject, must
include information about:
(i) the possibility that family members of the subject may learn genetic
information about the subject as a result of a project; and
(ii) the possibility that the project may determine that some family
members are not genetic relatives; and
(iii) the disposition of records and data generated during the project;
and
(c) the genetic information must only be disclosed according to the
requirements of this Act.
(1) Any person who stores genetic information of 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 must be provided
with individual identifiers, or codes, or no identifiers, according to the
written authorisation of the subject
(2) Notwithstanding subsection (1), 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:
(a) 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
(b) the person conducting the inspection or review certifies in
writing:
(i) that the limitations in paragraph (a) will be complied with;
(ii) that the person has complied with this Act; and
(iii) that the person has knowledge of liability for breaches of this
Act.
(1) A DNA sample collected before the commencement of this Act may be
analysed as part of a research project, unless the individual involved, within 3
years of the commencement of this Act, submits a written request that such
sample be withdrawn or destroyed.
(2) Except as provided by this Act, 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.
(1) 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:
(a) consent to the transfer of the samples or records containing the
genetic information; or
(b) order that the samples or records be returned to the individual;
or
(c) order that the samples or records be destroyed.
(2) If, within a period of 3 months after notification, the person
identified in subsection (1) receives no response from the individual, the
person:
(a) may destroy the samples or the records if the activities or services
are discontinued; or
(b) may place the samples and research records, without individual
identifiers, in a tissue sample archive, according to prior instructions of the
individual; or
(c) may proceed with the intended transfer of the samples and
records.
(1) Where genetic information is available from genetic analysis before
the birth of a person and about that person's genome, the genetic information is
the genetic information of the person’s biological mother but becomes the
genetic information of that person when he or she is born alive.
(2) This section applies only to genetic information derived from the
genome of the person, and does not include genetic information about other
genomes.
(3) For the purposes of this Act, a person to whom subsection (1) applies
is an individual.
(1) 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.
(2) Where a complaint has been made to the Privacy Commissioner under this
section 43, Part V of the Privacy Act 1988 (except for paragraph 41(3)(a)
and subsections 41(4), 52(3A) and 63(1)) applies as if the complaint were a
complaint under section 36 of that Act.
(1) An individual may complaint 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.
(2) Where a complaint has been made to the Human Rights and Equal
Opportunity Commissioner under this section, Division 3 of Part II of the
Human Rights and Equal Opportunity Commission Act 1986 (except for
section 29) applies as if the complaint were a complaint under section 20 of
that Act.
(1) This Part applies only if Part 7 does not apply.
(2) 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.
(3) In any action brought under this section, a court may order:
(a) a person to comply with the provisions of this Act; and
(b) any other appropriate equitable relief.
(4) 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, is liable to the individual for
each such breach in an amount equal to:
(a) any actual damages sustained as a result of the collection, storage,
or analysis, or $50 000, or an amount determined by the court, whichever is
greatest; and
(b) in any case in which such breach has resulted in profit or monetary
gain, treble damages; and
(c) in the case of a successful action under this section, the costs of
the action and reasonable costs as determined by the court.
(5) 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:
(a) any actual damages sustained as a result of the collection, storage,
or analysis, or $100,000, or an amount determined by the court, whichever is
greatest; and
(b) such punitive damages as the court may allow; and
(c) in the case of a successful action under this section, the costs of
the action as determined by the court.
The following written statement must 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.