STEM CELL THERAPY > INFORMATION > SHEET 3

Legal and Regulatory Issues

The legal and regulatory state of stem cell therapy is currently undergoing review. It should be noted that links suggested below are visited to get the most up to date regulations. Human reproductive cloning remains illegal in the UK.

HFEA and the HGAC

Research on therapeutic cloning is ruled out because it does not fall within the permitted reasons for the creation and maintenance of embryos outside of the human body as laid down in the Human Fertilisation and Embryology Act.

Under the terms of the Act a specific HFEA licence is required for any research that involves the creation, keeping or use of human embryos outside the body. The HFEA cannot grant a licence unless it is satisfied that the use of human embryos is essential for the research, which must be for one of the following purposes:

• to promote advances in the treatment of infertility
• to increase knowledge about the causes of congenital disease
• to increase knowledge about the causes of miscarriages
• to develop more effective techniques of contraception, or to develop methods for detecting the presence of gene or chromosome abnormalities in embryos before implantation.

In their joint report of December 1998, Cloning: Issues in Reproductive Science and Medicine, the HFEA and the Human Genetics Advisory Commission recommended that the purposes for which human embryos may be used in research under UK legislation should be extended to include research to develop methods of therapy for:

mitochondrial diseases

diseased or damaged tissues or organs

Government Legislation

Three new categories for which human embryo research is permitted were authorised, this came into force on 31 January 2001. These are:

• Increasing knowledge about the development of embryo's
• Increasing knowledge about serious disease
• Enabling any such knowledge to be applied in developing treatments for serious disease.

The Donaldson Report

The report of the CMO's Expert Group on Therapeutic Cloning - " Stem Cells: Medical Progress with Responsibility " was published on 16 August 2000.

Scientific evidence provided to the Group indicated that stem cells have enormous potential as a source of new tissue for therapeutic use. The Group concluded that research was warranted across a range of sources of stem cells, including embryos created by in vitro fertilisation or cell nuclear replacement. While recognising the views of those opposed to embryo research on ethical grounds, the Group concluded that the proposed new research did not raise fundamentally new ethical issues, different from those raised by currently permitted forms of embryo research. There is already a well-established framework for the control of embryo research under the Human Fertilisation and Embryology Act 1990, which would provide the necessary safeguards for this new research.

The Group makes a number of recommendations to enable and monitor developments in stem cell research. These include a call for research councils to fund research into stem cells, including alternative sources of stem cells, and to establish collections of embryonic stem cells to minimise the need for the use of embryos in this research and for the importation of stem cell lines.

Nuffield Report

The Nuffield Council on Bioethics had this to say in the summary of their 2000 Report - 'Stem Cell Therapy: the ethical issues, a discussion paper': "We consider that the removal and cultivation of cells from a donated embryo does not indicate lack of respect for the embryo.

This research involves using the embryo as a means to an end but, since we accept the morality of doing so in relation to currently authorised embryo research, there seems to be no good reason to disallow research on the embryo where the aim is to develop therapies for others.

We therefore recommend that research involving human embryos be permitted for the purpose of developing tissue therapies from the derived ES cells and that Schedule 2 of the HFE Act be amended accordingly."

Brief details of the laws in some other countries

Laws concerning the derivation and use of stem cells from human embryos are currently in a state of flux in Europe and Australia.

Scientists, lawyers, ethicists and legislators worldwide are grappling with whether it is permissible to use what are, in most cases, excess embryos from in vitro fertilisation treatments, to derive these master cells which can develop into all of the body's cells and tissues.

Human cloning is widely banned in Canada and by the European parliament and is generally condemned elsewhere. Three main arguments for this are:

• It experiments with the life of a foetus
• It threatens individuality
• It turns procreation into a form of manufacturing.

However, advocates say it would help infertile couples and those whose children have died. It would also provide a source of cells for transplantation and for research.