30 November 2005
Draft guidelines for using human embryonic stem cells for research released for consultation
The Ministry of Health is inviting submissions on a draft paper that sets out proposed guidelines for research using
imported stem cell lines from human embryos.
The "Guidelines on Using Stem Cells from Established Human Embryonic Stem Cell Lines for Research" discussion document
was released by the Ministry for public consultation today.
The Principal Advisor in the Ministry's Sector Policy Directorate, John Hobbs, says discussions around human embryonic
stem cell research is likely to be a sensitive ethical issue for some people. The Ministry is also aware that delays in
clarifying the regulation of human embryonic stem cell research could hinder scientists' opportunities to develop future
capabilities in this field of research.
"As a result wide public consultation is being undertaken on the proposed guidelines so that any issues that this type
of research raises can be clarified. The proposed guidelines would place appropriate restrictions around research and
provide certainty for researchers, ethics committees and the public," Mr Hobbs says.
Any research involving human embryos comes under the statutory control of the Human Assisted Reproductive Technology Act
2004. The legislation however, does not cover the use of existing embryonic stem cell lines for non-reproductive
Human embryonic stem cells are cells from embryos that can self replicate in the laboratory and remain undifferentiated
outside the human body over a length of time. Research using embryonic stem cells is not currently undertaken in New
The draft guidelines include provisions around ethical review; provisions associated with the way in which human
embryonic stem cell lines are established; provisions relating to the proposed use of established human embryonic stem
cell lines and duties of ethics committees.
The closing date for submissions on the draft guidelines is Friday 3 March 2006.
Copies of the Guidelines on Using Cells from Established Human Embryonic Stem Cell Lines for Research: Discussion
Document can be downloaded from the Ministry of Health website http://www.moh.govt.nz/publications
Questions and Answers
What are embryonic stem cells?
Four or five days after an egg is fertilized by a sperm, the embryo forms a hollow mass of cells called a blastocyt.
This consists of an outer and inner group of cells. The cells from the inner cell mass can be isolated and grown in
culture in the lab and used for research purposes. Established human embryonic stem cell lines are stable groups of
undifferentiated cells that can self replicate and remain unchanged for long periods of time outside of the body. Human
embryonic stem cell lines are derived from cells in embryos but are not embryos themselves and therefore, cannot be used
to create a foetus or a human being. The main reasons currently why research on human embryonic stem cell lines may be
carried out is to understand cell growth and the causes of developmental abnormalities.
Do the draft guidelines consider possible ethical issues with this type of research?
Research using stem cells from established human embryonic stem cell lines raises a number of ethical issues and views
on this type of research do vary. At the moment most of the research into these cell lines is basic biological work
looking into how different embryonic stem cells work. It is likely to be many years before this research could be used
in human health to treat disease and a cautious approach will be necessary around discussing the potential benefits of
this type of research in the future. Under the draft guidelines, all research proposals involving established human
embryonic stem cells would be required to be approved by an accredited ethics committee before the research could take
What are the benefits associated with this type of research?
Research on human embryonic stem cells is at an early stage. At the moment, most such research is basic biological
research whose aims include learning how to control the differentiation of embryonic stem cells into different cell
types and investigating the effects of embryonic stem cells in animal models of disease. Therapies to treat disease and
relieve human suffering will not be developed from human embryonic stem cells for a number of years. Nevertheless, the
fact that human embryonic stem cell research may one day lead to improvements in human health and the alleviation of
suffering is an important justification for such research. Most researchers see the main goal of human embryonic stem
cell research to be the development of new therapies through the discipline of regenerative medicine. Because human
embryonic stem cells are able to give rise to any type of cell, they may be able to be used to replace cells lost
through injury or disease, for example diabetes, neurological conditions, and autoimmune diseases.
What legislation covers this type of research?
There are a number of laws relevant to the regulation of research using cells from established human embryonic stem cell
lines. Outside of the new draft guidelines, stem cell researchers are also required to meet their obligations under
existing laws including:
· the Human Assisted Reproductive Technology (HART) Act 2004 · the Human Tissue Act 1964, currently under review · the
Hazardous Substances and New Organisms (HSNO) Act 1996 · the New Zealand Public Health and Disability Act 2000 · the
Medicines Act 1981, currently under review.
What is the Human Assisted Reproductive Technology Act 2004?
The HART Act outlines the rules for human reproductive technology in New Zealand. In August this year the Act saw the
establishment of the Advisory Committee on Assisted Reproductive Technology (ACART) and the ethics committee.
Researchers wanting to undertake work that creates or uses human embryos are required to gain ethical approval. Ethical
approval may only be given once ACART has developed and consulted on embryonic research guidelines. The use of
established human embryo stem cells for reproductive research also requires ethics approval under the Act. The Human
Assisted Reproductive Technology Act 2004 does not cover the use of established embryonic stem cells for
non-reproductive research purposes. This is why guidelines have been proposed.
The Ministry is also currently reviewing the regulation of human tissue and tissue-based therapies. Proposed Human
Tissue legislation would cover the use of all human tissues including existing human embryonic stem cell lines. It is
proposed that guidelines for the importation of established human embryonic stem cell lines will be incorporated into
import/export guidelines to be developed for human tissue.
Why do we need guidelines on established human embryo stem cell line research?
Human embryonic stem cell research is carried out in most jurisdictions in the developed world, under a variety of
regulatory systems. Although legislation and regulations relevant to human embryonic stem cell research already exist in
New Zealand, there is no guidance specific to this research, and no such research takes place in this country.
Guidelines are needed to clarify the issues that this type of research raises, to place appropriate restrictions on such
research and to provide certainty for researchers, ethics committees and members of the public.
What do the draft guidelines recommend?
In their current form, the draft guidelines would allow researchers to import and use, with a number of restrictions,
cells from established human embryonic stem cell lines. This approach is in line with other countries such as Australia.
The draft guidelines set out the suggested process for getting ethical committee review for any proposed research, the
consent process for acquiring established human embryonic stem cell lines, and ethics committee duties.
Are established human embryonic stem cell lines used for research in New Zealand?
While this type of research is not currently undertaken in this country, researchers are interested in pursuing research
that uses embryonic stem cell lines.
What consultation has gone into drafting the proposed guidelines?
The Ministry of Health has sought comment and input from a number of sources including assistance from the National
Ethics Advisory Committee and the National Ethics Committee on Assisted Human Reproduction, the Health Research Council
of New Zealand, the Environmental Risk Management Authority, the Royal Society of New Zealand, and the Foundation for
Research Science and Technology. At all stages in the development of the draft discussion paper and guidelines,
comprehensive peer review was sought and provided.
How can the public comment on the draft guidelines?
Members of the public can provide comment on the Guidelines on Using Stem Cells from Established Human Embryonic Stem
Cell Lines for Research to the Ministry of Health by Friday 3 March 2006 at 5pm. Submission forms can be downloaded in
from http://www.moh.govt.nz/publications and responses emailed to firstname.lastname@example.org. Alternatively submissions can
be posted to Sector Policy, Ministry of Health, PO Box 5013 Wellington.
All submissions will be analysed before draft guidelines are finalised and sent to the Minister of Health for final
approval. If there is sufficient demand oral submissions will be also be heard.