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Genetic Privacy and Non-discrimination Bill 1998 [2008]

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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 ”.