Draft guidelines for stem cells

Media Release

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 research.

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 Zealand.

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 place.

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 tanith_robb@moh.govt.nz. 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.

ENDS

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