StemCell Therapy

Stem cell laws are the law rules, and policy governance concerning the sources, research, and uses in treatment of stem cells in humans. These laws have been the source of much controversy and vary significantly by country.[1] In the European Union, stem cell research using the human embryo is permitted in Sweden, Finland, Belgium, Greece, Britain, Denmark and the Netherlands; however, it is illegal in Germany, Austria, Ireland, Italy, and Portugal. The issue has similarly divided the United States, with several states enforcing a complete ban and others giving financial support.[2] Elsewhere, Japan, India, Iran, Israel, South Korea, China, and Australia are supportive. However, New Zealand, most of Africa (except South Africa), and most of South America (except Brazil) are restrictive.

The information presented here covers the legal implications of embryonic stem cells (ES), rather than induced pluripotent stem cells (iPSCs). The laws surrounding the two differ because while both have similar capacities in differentiation, their modes of derivation are not. While embryonic stem cells are taken from embryoblasts, induced pluripotent stem cells are undifferentiated from somatic adult cells.[3]

Stem cell are cells found in most, if not all, multi-cellular organisms. A common example of a stem cell is the Hematopoietic stem cell (HSC) which are multipotent stem cells that give rise to cells of the blood lineage. In contrast to multipotent stem cells, embryonic stem cells are pluripotent and are thought to be able to give rise to all cells of the body. Embryonic stem cells were isolated in mice in 1981, and in humans in 1998.[4]

Stem cell treatments are a type of cell therapy that introduce new cells into adult bodies for possible treatment of cancer, Somatic cell nuclear transfer, diabetes, and other medical conditions. Cloning also might be done with stem cells. Stem cells have been used to repair tissue damaged by disease.[5]

Because Embryonic Stem (ES) cells are cultured from the embryoblast 45 days after fertilization, harvesting them is most often done from donated embryos from in vitro fertilization (IVF) clinics. In January 2007, researchers at Wake Forest University reported that "stem cells drawn from amniotic fluid donated by pregnant women hold much of the same promise as embryonic stem cells."[4]

In 2000, the NIH, under the administration of President Bill Clinton, issued guidelines that allow federal funding of embryonic stem-cell research.[4]

The European Union has yet to issue consistent regulations with respect to stem cell research in member states. Whereas Germany, Austria, Italy, Finland, Greece, Ireland, Portugal and the Netherlands prohibit or severely restrict the use of embryonic stem cells, Sweden and the United Kingdom have created the legal basis to support this research.[6]Belgium bans reproductive cloning but allows therapeutic cloning of embryos.[1]France prohibits reproductive cloning and embryo creation for research purposes, but enacted laws (with a sunset provision expiring in 2009) to allow scientists to conduct stem cell research on imported a large amount of embryos from in vitro fertilization treatments.[1]Germany has restrictive policies for stem cell research, but a 2008 law authorizes "the use of imported stem cell lines produced before May 1, 2007."[1]Italy has a 2004 law that forbids all sperm or egg donations and the freezing of embryos, but allows, in effect, using existing stem cell lines that have been imported.[1]Sweden forbids reproductive cloning, but allows therapeutic cloning and authorized a stem cell bank.[1][6]

In 2001, the British Parliament amended the Human Fertilisation and Embryology Act 1990 (since amended by the Human Fertilisation and Embryology Act 2008) to permit the destruction of embryos for hESC harvests but only if the research satisfies one of the following requirements:

The United Kingdom is one of the leaders in stem cell research, in the opinion of Lord Sainsbury, Science and Innovation Minister for the UK.[7] A new 10 million stem cell research centre has been announced at the University of Cambridge.[8]

The primary legislation in South Africa that deals with embryo research is the Human Tissue Act, which is set to be replaced by Chapter 8 of the National Health Act. The NHA Chapter 8 has been enacted by parliament, but not yet signed into force by the president. The process of finalising these regulations is still underway. The NHA Chapter 8 allows the Minister of Health to give permission for research on embryos not older than 14 days. The legislation on embryo research is complemented by the South African Medical Research Council's Ethics Guidelines. These Guidelines advise against the creation of embryos for the sole purpose of research. In the case of Christian Lawyers Association of South Africa & others v Minister of Health & others[9] the court ruled that the Bill of Rights is not applicable to the unborn. It has therefore been argued based on constitutional grounds (the right to human dignity, and the right to freedom of scientific research) that the above limitations on embryo research are overly inhibitive of the autonomy of scientists, and hence unconstitutional.[10]

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Stem cell laws - Wikipedia, the free encyclopedia

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