Australia Parliament and Prime Minister Letter From Christopher Reeve Delivered By Perry Cross - June 26, 2002

An open letter to all members of the Australian Parliament, and the people of Australia.

I wish to congratulate the Australian state governments and federal parliament on their vision and determination to advance world science and in particular human embryonic stem cell research.

Your support for human ESC research will give many millions of people all over the world hope for a better life. I am confident the promise of stem cell research will be delivered in the years to come. Already we are witnessing significant advances in many therapies related to advances in stem cell research.

Australia's stem cell scientists are recognised around the globe. Your decision to support their research will ensure Australia continues to be a world leader in this exciting field. The benefits to the people of Australia, ensuring the earliest possible access to new therapies and treatments, are immense.

for this reason I would say Australia is truly a lucky country.

My circumstances unfortunately prevent a visit to Australia at this time. I do however look forward to the day when I might walk with my family along your beautiful pristine shores.

With my very warmest wishes for your continued success.

Christopher Reeve

2002

THE PARLIAMENT OF THE COMMONWEALTH OF AUSTRALIA

HOUSE OF REPRESENTATIVES

RESEARCH INVOLVING EMBRYOS AND PROHIBITION OF HUMAN CLONING BILL 2002

EXPLANATORY MEMORANDUM

(Circulated by authority of the Prime Minister, the Hon John Howard MP)

RESEARCH INVOLVING EMBRYOS AND PROHIBITION OF HUMAN CLONING BILL 2002

OUTLINE

This Bill forms part of a national regulatory system to address concerns, including ethical concerns, about scientific developments in relation to human reproduction and the utilisation of human embryos. This is to be achieved through a regulatory framework which:

1. prohibits certain practices associated with reproductive technologies, including the cloning of a human being; and
2. regulates activities that involve the use of certain human embryos created by assisted reproductive technology.

Consistent with its object, the Bill:

1. prohibits the creation, importation, exportation or implantation of a human embryo clone;
2. prohibits the creation, importation, exportation or implantation of certain other embryos for ethical and safety reasons;
3. establishes a principal committee within the National Health and Medical Research Council (NHMRC), the NHMRC Embryo Research Licensing Committee (the NHMRC Licensing Committee), for the purposes of performing functions and exercising powers under the Bill;
4. establishes a scheme for the assessment and licensing of certain activities involving the use of excess embryos created by assisted reproductive technology (excess ART embryos); and
5. provides for a centralised, publicly available database of information about all licences issued by the NHMRC Licensing Committee.

FINANCIAL IMPACT STATEMENT

In developing and implementing the Research Involving Embryos and Prohibition of Human CLONING BILL 2002, the Government will incur both establishment costs and ongoing costs.

Following the passage of the legislation, costs are realistically expected to be approximately $3m per annum, with an upper maximum of $6m. This involves a fixed cost to support the NHMRC Licensing Committee and provide for ongoing compliance monitoring related to the prohibited practices. There is also a variable cost, related to the number of applications received. While it is not possible to accurately predict this, the above estimate includes up to 120 applications per year, based on recent consultation with ART service providers and researchers. Establishment costs involve:

• developing administrative processes for receiving and processing applications and issuing licences;
• establishing the new NHMRC Licensing Committee;
• recruiting appropriately skilled staff;
• establishing a skilled inspectorate to ensure compliance with the Act through monitoring and inspection;
• assessment of research proposals; and
• establishment and maintenance of data systems and public reporting.

REGULATION IMPACT STATEMENT

Please refer to Attachment 1 to this Explanatory Memorandum.

RESEARCH INVOLVING EMBRYOS AND PROHIBITION OF HUMAN CLONING BILL 2002

NOTES ON CLAUSES

PART 1 - PRELIMINARY

Clause 1 Short title

This is a formal provision that specifies the short title of the Bill as the Research Involving Embryos and Prohibition of Human Cloning Act 2002.

Clause 2 Commencement

Sub-clause 2(1) provides that the various provisions take effect on the date specified in the table.

Item 1 of the table provides that clauses 1 and 2 of the Bill commence on the day on which the Bill receives Royal Assent.

Item 2 of the table provides that clauses 3 to 24 will commence 28 days after the day on which the Bill receives Royal Assent. These clauses relate to the preliminary matters in the Bill and to the prohibited practices included in Part 2 of the Bill.

Item 3 of the table provides that clauses 25 to 27 will commence 6 months after the day on which the Bill receives Royal Assent. Clause 25 provides that a person must not use an excess ART embryo unless that use is an exempt use or is authorised by a licence issued by the NHMRC Embryo Research Licensing Committee. Clause 26 provides that a person must not use a non-excess ART embryo unless it is part of an ART program carried out by an accredited ART centre. Clause 27 provides that a person must comply with any conditions of a licence.

The delay of commencement for these clauses is to allow time:

• for the establishment of the new NHMRC Licensing Committee; and
• for applications for licences to be made.

During this 6 month transitional period researchers and others will continue to have to comply with existing State legislation and the NHMRC Ethical Guidelines on ART (1996).

By delaying the commencement of these clauses for 6 months this will also allow States and Territories to introduce complementary legislation and, where necessary, repeal existing provisions of State legislation that ban the use of excess ART embryos.

Item 4 and Item 5 of the table provides that clauses 28 to 62 and Schedule 1 will commence 28 days after the day on which the Bill receives Royal Assent. These clauses provide, among other things, for the establishment and administration of the NHMRC Licensing Committee as well as provisions on the review of the Act and regulations to be made under the Act. Schedule 1 repeals certain sections of the Gene Technology Act 2000 that are replaced by clauses in Part 2 of this Bill.

Clause 3 Object of Act

This clause provides that the object of this Bill is to address concerns, including ethical concerns, about scientific developments in relation to human reproduction and the utilisation of human embryos:

1. by prohibiting certain practices; and
2. by regulating activities that involve the use of certain human embryos created by assisted reproductive technology.

Clause 4 Operation of Act

This clause sets out the constitutional powers on which it is proposed that the Commonwealth legislation will rely.

The Commonwealth legislation will rely on:

• the Corporations power (paragraph 51(xx) of the Constitution). This means that the Act will apply to all things done by corporations formed within the limits of the Commonwealth;
• the trade and commerce power (paragraph 51(i) of the Constitution). This means that the Act will apply to all things done in the course of trade and commerce;
• the external affairs power (paragraph 51(xxix) of the Constitution). This enables the Act to apply to matters of international concern;
• powers of the Parliament in relation to the Commonwealth (section 52 of the Constitution). This means the Act will apply to all things done by the Commonwealth and Commonwealth authorities (including Commonwealth Departments such as the Department of Health and Ageing, Commonwealth statutory authorities and Commonwealth companies);
• the census and statistics power (paragraph 51(xi) of the Constitution). This enables the Act to apply for purposes relating to the collection, compilation, analysis and dissemination of statistics (such as the provisions relating to the establishment of a database of licences issued by the NHMRC Licensing Committee); and
• incidental power (paragraph 51(xxxix) of the Constitution). This enables the establishment of the infrastructure necessary to support the regulatory system.

Clause 5 Act to bind the Crown

Sub-clause 5(1) provides that the Bill will bind the Crown in each of its capacities.

Sub-clause 5(2) provides that the Crown may not be prosecuted for a criminal offence under this Bill.

Clause 6 External Territories

This clause provides that the Bill will have application in every external Territory. Therefore, the legislation will cover, for example, Norfolk Island, the Indian Ocean Territories (Cocos and Christmas Islands), Macquarie and Heard Islands, the Australian Antarctic Territory and the Jervis Bay Territory.

Clause 7 Definitions

This clause sets out a number of definitions for words and phrases used in the Bill. These definitions determine the meaning that is to be attributed to certain words or phrases whenever they are used in the Bill or regulations. Key definitions, which are essential to defining the scope of the legislation and describing how it will be administered, include the following.

human embryo which is defined to mean a live embryo that has a human genome or an altered human genome, that has been developing for less than 8 weeks since:

• the appearance of 2 pro-nuclei; or
• the initiation of development by other means.

This definition is intended to include:

1. a human embryo created by the fertilisation of a human egg by human sperm.

The Bill relies upon the appearance of 2 pro-nuclei to establish the existence of a human embryo that has been created by the fertilisation of a human egg by human sperm. The appearance of the pro-nuclei indicates that the nuclei from the sperm and the egg are aligning prior to possible fusion. For the purposes of this legislation, the 8 weeks of development is taken to start with the appearance of 2 pro-nuclei. The legislation does not rely on defining when fertilisation commences or is complete.

2. a human embryo that has had its development initiated by any means other than by the fertilisation of a human egg by human sperm.

It is intended that the definition includes the following types of embryos:

• a human egg that has had its nucleus replaced by the nucleus of a somatic cell (ie a cell from the body) by the process referred to as somatic cell nuclear transfer (SCNT); and
• a parthenogenetic human embryo. It is possible that a human egg could be mechanically or chemically stimulated to undergo spontaneous activation and exhibit some of the characteristics of a fertilised human egg. A parthenogenetic human embryo has the capacity to continue its development in a similar manner to a human embryo created by fertilisation.

It should be noted that the procedures o