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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.
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
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
• 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;
• 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 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.
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
• 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.
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”.