Views on human gamete and embryo research wanted

Media Release

15 December 2006

New Zealanders’ views on human gamete and embryo research wanted

New Zealanders’ views on allowing human gamete and embryo research and, if so, the conditions which should apply, are being sought by the Government’s advisory committee on assisted reproductive technology.

ACART, the Advisory Committee on Assisted Reproductive Technology, today published a discussion paper which will inform Government policy on this issue. Use of Gametes and Embryos in Human Reproductive Research: Determining Policy for New Zealand presents information from a variety of perspectives: scientific, ethical, cultural, legal and policy as well as seeking submissions to the Committee.

“New Zealanders have had limited opportunity to date to influence policy on gamete and embryo research” says Professor Sylvia Rumball, Chair of ACART.

“We expect that there will be many different views and ACART hopes to hear them all before it decides what advice it will give to the Minister of Health. I encourage all New Zealanders to take part in this discussion.”

Internationally, scientific developments involving the use of gametes and embryos in research are taking place. These developments further our understanding of normal growth and development. New Zealand researchers would like the opportunity to contribute to this work. However, the use of gametes and embryos for research raises ethical, cultural and spiritual issues, which must be considered. ACART will provide the Minister of Health with advice on the use of gametes and embryos in research following this consultation.

Submissions close on 2 March 2007. Please visit ACART’s website for a copy of the discussion paper and further information: www.newhealth.govt.nz/acart.

For further media information contact:

Chair, Advisory Committee on Assisted Reproductive Technology (ACART)
Professor Sylvia Rumball
Phone: (06) 350 5249
(021) 535 001

Media advisor:
Ministry of Health
Rebecca Walsh
Phone: (04) 496 2115
(021) 277 5411

Questions and Answers

What is the HART Act?
The Human Assisted Reproductive Technology Act 2004 provides the legislative framework that prohibits or allows some procedures, and requires that others be subject to ethical review on a case by case basis before going ahead. The Act identifies where further advice is required on areas of treatment or research, as well as procedures for developing this advice.

What is ACART?
ACART is an independent Advisory Committee set up under the HART Act to advise the Minister on assisted reproductive procedures and human reproductive research. It has 12 members.

ACART must include:
• one or more members with expertise in assisted reproductive procedures
• one or more members with expertise in human reproductive research
• one or more members with expertise in ethics
• one or more Māori members with expertise in Māori customary values and practice and the ability to articulate issues from a Māori perspective
• one or more members with the ability to articulate issues from a consumer perspective
• one or more members with expertise in relevant areas of the law
• one or more members with the ability to articulate the interests of children. Any person appointed under this requirement must be the Commissioner for Children, or a representative or employee of the person who holds that office.

At least half the members of ACART must be lay persons.

ACART is a diverse committee that has been composed to represent a wide-cross section of New Zealand society.

What is human reproductive research?
Human reproductive research means research that uses or creates a human gamete (sperm or eggs) or a human embryo. This topic is the focus of ACART’s current discussion paper and consultation. There is a link, however, between research and infertility treatment in that treatment is one possible source of embryos for research; and also people will need to make decisions about what to do with any embryos that will not be implanted – one possible use is donation for research.

What is an assisted reproductive procedure?
An assisted reproductive procedure is a procedure performed for the purpose of assisting human reproduction (ARP). The most commonly referred to ARP is in vitro fertilization (IVF) where sperm and eggs are combined outside the body and an embryo is subsequently replaced into the uterus of the woman.

ACART will be consulting separately on assisted reproductive procedures, in April 2007.

What is a gamete?
The HART Act defines a gamete as
• a human egg or sperm, whether mature or not, or
• any other cell (whether naturally occurring or artificially formed or modified) that
- contains only one copy of all or most chromosomes and
- is capable of being used for reproductive purposes.

What is an embryo?
The HART Act defines an embryo as including a zygote and a cell or group of cells that has the capacity to develop into an individual; but does not include stem cells derived from an embryo.

Under the HART Act, it is an offence to possess or use an embryo outside the womb beyond 14 days. All references, therefore, to research using embryos mean an embryo up to and including the 14th day after its formation (sometimes called the ‘pre-embryo’)

Why might we conduct research using human gametes and embryos?
Internationally, scientific developments involving the use of gametes and embryos in research are taking place. These developments have the potential to further our understanding of various disease states as well as our understanding of normal growth and development. New Zealand researchers would like the opportunity to contribute to this work.

In ACART’s discussion paper, the use of gametes and embryos for research could potentially result in any or all of the following four purposes:
• contribution to an understanding of fundamental science, for example, a better understanding of the developmental pathways that lead to the birth of healthy babies can contribute to an understanding of the causes of foetal developmental abnormalities
• contribution to understanding of fertility and infertility
• contribution to prevention of hereditary diseases, for example, through using pre-implantation genetic diagnosis to check for genetic or chromosomal disorders in embryos in order to select only healthy embryos for implantation
• contribution to treating human disease in general through, for example, the potential for embryonic stem cells to give rise to any type of cell and thus replace cells lost through injury or disease (such application is, however, unlikely to be realised in the near future).

Where will the embryos for any approved research come from?
This will be decided following consultation. However, in its discussion paper, ACART identifies three potential sources of embryos for use in research:
• Non-viable embryos that lack the capacity to develop into an individual even if implanted.
• Surplus embryos left over from IVF procedures
• Embryos created specifically for research either by IVF procedures or through cloning.

Currently, in New Zealand, only non-viable embryos can be used for research.

What about embryonic stem cells?
Embryonic stem cells are cells found in the early embryo that have not yet developed into a specialised cell type (ie, they are undifferentiated) and have the potential to form all of the 200 types of cell that make up the human body (ie, they are pluripotent). Once isolated, they can be grown in culture to form embryonic stem cell lines in the laboratory and used for research purposes.

Once established, human embryonic stem cell lines are not embryos because they lack the capacity to develop into an individual. Therefore, their use is not covered by the HART Act.

Why is ACART consulting the public?
ACART is consulting the public because assisted reproductive procedures and human reproductive research are important issues for our society. People have a range of views based on their values which gives rise to significant ethical and moral debate.

The HART Act requires ACART to consult the public before giving advice to the Minister of Health or issuing guidelines to the Ethics Committee.

How is ACART conducting public consultation?
ACART is holding a multi-faceted consultation that involves:
• release of a discussion paper that outlines the issues involved with the use of gametes and embryos in research – people are encouraged to make written submissions
• holding focus groups
• running public meetings, hui and fono
• hearing formal oral submissions.

Information on where and when meetings will take place will be published on ACART’s website early in 2007 and advertised in newspapers close to the time they will be held.

How does ACART’s consultation fit with the Bioethics Council’s recent dialogue – Talking Embryos

ACART has the statutory responsibility to consult and advise the Minister on future policy on human reproductive research in New Zealand.

The Bioethics Council held the Talking Embryos dialogue to raise awareness and to encourage New Zealanders to think about embryo research prior to ACART’s consultation. The Bioethics Council will use the submissions people made to it during the Talking Embryos dialogue to make its submission to ACART. However, even if you made a submission to the Bioethics Council, ACART would like to hear from you directly.

Why did the Ministry of Health develop guidelines for using cells from established embryonic stem cell lines for research before ACART consulted the public?

The use of cells from established embryonic stem cells does not fall under the HART Act or ACART’s responsibilities, though the development of new stem cell lines from embryos does.

The Ministry of Health will review its guidelines following the outcome of ACART’s public consultation and consideration on research using human embryos, including their use to derive stem cell lines.

When do submissions close?
Submissions close at 5 pm on Friday 2 March 2007.

Who do I send my submission to?
Send your submission to the ACART Secretariat:

acart@moh.govt.nz

ACART Secretariat
P O Box 5013
Wellington

Can I make an oral submission?
Yes, the HART Act requires ACART to hear oral submissions if it considers that a significant number of people wish to make an oral submission. Making an oral submission provides you with an opportunity to explain your point of view to ACART in person. It also provides ACART with the opportunity to ask supplementary questions during your oral submission.

If you want to make an oral submission, you must let the ACART Secretariat know as soon as possible, and not later than 2 March 2007:
(acart@moh.govt.nz; (04) 496 2000; or P O Box 5013, Wellington).

Can I have a say about which infertility treatments we should approve for use in New Zealand?
Yes, ACART will be holding another consultation in early 2007 on the clinical application of assisted reproductive procedures. It will cover such issues as surrogacy and pre-implantation genetic diagnosis.

How will ACART formulate its advice to the Minister of Health?
ACART’s advice to the Minister of Health will be based in part on the submissions arising from this consultation. However, the submissions will be considered alongside other considerations such as existing policy in New Zealand, scientific and ethical analysis and the principles of the HART Act. ACART will advise the Minister by 30 June 2007. The Government will make the final decisions about New Zealand’s policy on gamete and embryo research.

What is happening in other countries?

Other countries have a range of positions on embryo research policy and legislation. The examples are set out below are grouped into four broad positions.

Position A
The use of embryos in research is banned.
The use of established human embryonic stem cells in research is banned. Position B
The use of embryos in research is banned.
The use of established human embryonic stem cells in research is not banned. Position C
The use of surplus IVF embryos in research is not banned.
The use of established human embryonic stem cells derived from such embryos in research is not banned. Position D
The use of embryos created for research and surplus IVF embryos in research is not banned.
The use of established human embryonic stem cells derived from such embryos in research is not banned.
Ireland
Austria
Norway
Poland
Germany
Italy
Canada
Australia
France
Czech Republic
Denmark
Finland
Greece
Hungary
Russia
Spain
Switzerland
Taiwan United Kingdom
Singapore
Belgium
China
India
Israel
Netherlands
South Korea
Sweden

The United States is not included in this table as there has been little by way of regulation, and what regulation there has been does not apply to the private sector. Further, regulatory positions vary widely between states.

Where can I get more information?
You can get more information from ACART’s website at www.newhealth.govt.nz/acart

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