Stem cell laws

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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, Spain, Finland, Belgium, Greece, Britain, Denmark and the Netherlands; [2] 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 support. [3] 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.

Contents

Science background

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. [4]

Stem cells 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. [5]

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. [6]

Because ES cells are cultured from the embryoblast 4–5 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." [5]

Europe

The European Union has yet to issue consistent regulations with respect to stem cell research in member states. Whereas Germany, Austria, Italy, Finland, Portugal and the Netherlands prohibit or severely restrict the use of embryonic stem cells, Greece, Sweden, Spain and the United Kingdom have created the legal basis to support this research. [7] 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] [7]

According to modern stem cell researchers, Spain is one of the leaders in stem cell research and currently has one of the most progressive legislations worldwide with respect to human embryonic stem cell (hESC) research. [8] The new Spanish law allows existing frozen embryos – of which there are estimated to be tens of thousands in Spain – to be kept for patient's future use, donated for another infertile couple, or used in research. [9] In 2003, Spain's laws state that embryos left over from IVF and donated by the couple that created them can be used in research, including ES cell research, if they have been frozen for more than five years. [10]

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:

  1. Increases knowledge about the development of embryos,
  2. Increases knowledge about serious disease, or
  3. Enables any such knowledge to be applied in developing treatments for serious disease.

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. [11] A new £10 million stem cell research centre has been announced at the University of Cambridge. [12]

Africa

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 [13] 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. [14]

Asia

China prohibits human reproductive cloning but allows the creation of human embryos for research and therapeutic purposes. [1] India banned in 2004 reproductive cloning, permitted therapeutic cloning. [1] In 2004, Japan’s Council for Science and Technology Policy voted to allow scientists to conduct stem cell research for therapeutic purposes, though formal guidelines have yet to be released. [1] In December 2012, Japanese Prime Minister, Shinzō Abe, announced an investment into regenerative medicine of ¥110 billion (US$1 billion) over the next decade. [15] The South Korean government promotes therapeutic cloning, but forbids cloning. [1] The Philippines prohibits human embryonic and aborted human fetal stem cells and their derivatives for human treatment and research. In 1999, Israel passed legislation banning reproductive, but not therapeutic, cloning. [1] [7] Saudi Arabia religious officials issued a decree that sanctions the use of embryos for therapeutic and research purposes. [1] According to the Royan Institute for Reproductive Biomedicine, Iran has some of the most liberal laws on stem cell research and cloning. [16] [17] Laws and regulations in Jordan allow stem-cell research. [18] A center for stem cell research has acquired a license to begin operating in April 2017 at the University of Jordan. [19]

Americas

Brazil

Brazil has passed legislation to permit stem cell research using excess in vitro fertilized embryos that have been frozen for at least three years. [1]

United States

Federal law places restrictions on funding and use of hES cells through amendments to the budget bill. [20] In 2001, George W. Bush implemented a policy limiting the number of stem cell lines that could be used for research. [5] There were some state laws concerning stem cells that were passed in the mid-2000s. New Jersey's 2004 S1909/A2840 specifically permitted human cloning for the purpose of developing and harvesting human stem cells, and Missouri's 2006 Amendment Two legalized certain forms of embryonic stem cell research in the state. On the other hand, Arkansas, Indiana, Louisiana, Michigan, North Dakota and South Dakota passed laws to prohibit the creation or destruction of human embryos for medical research. [20]

During Bush's second term, in July 2006, he used his first Presidential veto on the Stem Cell Research Enhancement Act. The Stem Cell Research Enhancement Act was the name of two similar bills, and both were vetoed by President George W. Bush and were not enacted into law. New Jersey congressman Chris Smith wrote the Stem Cell Therapeutic and Research Act of 2005, which made some narrow exceptions, and was signed into law by President Bush.

In November 2004, California voters approved Proposition 71, creating a US$3 billion state taxpayer-funded institute for stem cell research, the California Institute for Regenerative Medicine. It hopes to provide $300 million a year.

Barack Obama removed the restriction of federal funding signed by Bush in 2001, which only allowed funding on the 21 cell lines already created. However, the Dickey Amendment to the budget, The Omnibus Appropriations Act of 2009, still bans federal funding of creating new cell lines. In other words, the federal government will now fund research which uses the hundreds of more lines created by public and private funds. [21]

Canada

In March 2002, the Canadian Institutes of Health Research announced the first ever guidelines for human pluripotent stem cell research in Canada. The federal granting agencies, CIHR, Natural Sciences and Engineering Research Council, and Social Sciences and Humanities Research Council of Canada teamed up and agreed that no research with human IPSCs would be funded without review and approval from the Stem Cell Oversight Committee (SCOC). [22]

In March 2004, Canadian parliament enacted the Assisted Human Reproduction Act (AHRA), modeled on the United Kingdom’s Human Fertilization and Embryology Act of 1990. Highlights of the act include prohibitions against the creation of embryos for research purposes and the criminalization of commercial transactions in human reproductive tissues. [23]

In 2005, Canada enacted a law permitting research on discarded embryos from in vitro fertilization procedures. However, it prohibits the creation of human embryos for research. [1]

On June 30, 2010, The Updated Guidelines for Human Pluripotent Stem Cell Research outline that:

  1. The embryos used must originally have been created for reproductive purposes
  2. The persons for whom the embryos were created must provide free and informed consent for the unrestricted research use of any embryos created, which are no longer required for reproductive purposes
  3. The ova, sperm, nor embryo must not have been obtained through commercial transactions [22]

Canada's National Embryonic Stem Cell Registry:

Oceania

Australia is partially supportive (exempting reproductive cloning yet allowing research on embryonic stem cells that are derived from the process of IVF). New Zealand, however, restricts stem cell research. [24]

See also

Related Research Articles

<span class="mw-page-title-main">Human cloning</span> Creation of a genetically identical copy of a human

Human cloning is the creation of a genetically identical copy of a human. The term is generally used to refer to artificial human cloning, which is the reproduction of human cells and tissue. It does not refer to the natural conception and delivery of identical twins. The possibilities of human cloning have raised controversies. These ethical concerns have prompted several nations to pass laws regarding human cloning.

<span class="mw-page-title-main">Stem cell</span> Undifferentiated biological cells that can differentiate into specialized cells

In multicellular organisms, stem cells are undifferentiated or partially differentiated cells that can change into various types of cells and proliferate indefinitely to produce more of the same stem cell. They are the earliest type of cell in a cell lineage. They are found in both embryonic and adult organisms, but they have slightly different properties in each. They are usually distinguished from progenitor cells, which cannot divide indefinitely, and precursor or blast cells, which are usually committed to differentiating into one cell type.

<span class="mw-page-title-main">Somatic cell nuclear transfer</span> Method of creating a cloned embryo by replacing the egg nucleus with a body cell nucleus

In genetics and developmental biology, somatic cell nuclear transfer (SCNT) is a laboratory strategy for creating a viable embryo from a body cell and an egg cell. The technique consists of taking a denucleated oocyte and implanting a donor nucleus from a somatic (body) cell. It is used in both therapeutic and reproductive cloning. In 1996, Dolly the sheep became famous for being the first successful case of the reproductive cloning of a mammal. In January 2018, a team of scientists in Shanghai announced the successful cloning of two female crab-eating macaques from foetal nuclei.

<span class="mw-page-title-main">Human Fertilisation and Embryology Authority</span>

The Human Fertilisation and Embryology Authority (HFEA) is an executive non-departmental public body of the Department of Health and Social Care in the United Kingdom. It is a statutory body that regulates and inspects all clinics in the United Kingdom providing in vitro fertilisation (IVF), artificial insemination and the storage of human eggs, sperm or embryos. It also regulates human embryo research.

<span class="mw-page-title-main">Leon Kass</span> American academic (born 1939)

Leon Richard Kass is an American physician, scientist, educator, and public intellectual. Kass is best known as a proponent of liberal arts education via the "Great Books," as a critic of human cloning, life extension, euthanasia and embryo research, and for his tenure as chairman of the President's Council on Bioethics from 2001 to 2005. Although Kass is often referred to as a bioethicist, he eschews the term and refers to himself as "an old-fashioned humanist. A humanist is concerned broadly with all aspects of human life, not just the ethical."

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Embryonic stem cells (ESCs) are pluripotent stem cells derived from the inner cell mass of a blastocyst, an early-stage pre-implantation embryo. Human embryos reach the blastocyst stage 4–5 days post fertilization, at which time they consist of 50–150 cells. Isolating the inner cell mass (embryoblast) using immunosurgery results in destruction of the blastocyst, a process which raises ethical issues, including whether or not embryos at the pre-implantation stage have the same moral considerations as embryos in the post-implantation stage of development.

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Stem cell research policy varies significantly throughout the world. There are overlapping jurisdictions of international organizations, nations, and states or provinces. Some government policies determine what is allowed versus prohibited, whereas others outline what research can be publicly financed. Of course, all practices not prohibited are implicitly permitted. Some organizations have issued recommended guidelines for how stem cell research is to be conducted.

<span class="mw-page-title-main">Human Fertilisation and Embryology Act 1990</span> United Kingdom legislation

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<span class="mw-page-title-main">2008 Michigan Proposal 2</span>

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<span class="mw-page-title-main">Human Reproductive Cloning Act 2001</span> United Kingdom legislation

The Human Reproductive Cloning Act 2001 was an Act of the Parliament of the United Kingdom "to prohibit the placing in a woman of a human embryo which has been created otherwise than by fertilisation". The act received Royal Assent on 4 December 2001.

The Hwang affair, or Hwang scandal, or Hwanggate, is a case of scientific misconduct and ethical issues surrounding a South Korean biologist, Hwang Woo-suk, who claimed to have created the first human embryonic stem cells by cloning in 2004. Hwang and his research team at the Seoul National University reported in the journal Science that they successfully developed a somatic cell nuclear transfer method with which they made the stem cells. In 2005, they published again in Science the successful cloning of 11 person-specific stem cells using 185 human eggs. The research was hailed as "a ground-breaking paper" in science. Hwang was elevated as "the pride of Korea", "national hero" [of Korea], and a "supreme scientist", to international praise and fame. Recognitions and honours immediately followed, including South Korea's Presidential Award in Science and Technology, and Time magazine listing him among the "People Who Mattered 2004" and the most influential people "The 2004 Time 100".

References

  1. 1 2 3 4 5 6 7 8 9 10 11 12 13 14 Ralston, Michelle (July 17, 2008). "Stem Cell Research Around the World". Pew Forum on Religion & Public Life. Pew Research Center. Archived from the original on November 9, 2008. Retrieved April 13, 2009.
  2. ↑ "Stem Cell Policy: World Stem Cell Map". www.mbbnet.umn.edu. Retrieved 2021-09-20.
  3. ↑ Mlsna, Lucas J. (2010). "Stem Cell Based Treatments and Novel Considerations for Conscience Clause Legislation". Indiana Health Law Review . 8 (2). United States: Indiana University Robert H. McKinney School of Law: 471–96. ISSN:1549-3199. LCCN:2004212209. OCLC: OCLC   54703225.
  4. ↑ Soldner F, Hockemeyer D, Beard C, Gao Q, Bell GW, Cook EG, Hargus G, Blak A, Cooper O, Mitalipova M, Isacson O, Jaenisch R (2009). "Parkinson's disease patient-derived induced pluripotent stem cells free of viral reprogramming factors". Cell. 136 (5): 964–77. doi:10.1016/j.cell.2009.02.013. PMC   2787236 . PMID   19269371.
  5. 1 2 3 John Ydstie and Joe Palca, "Embryonic Stem Cells Made Without Embryos," NPR, November 21, 2007, found at NPR website story of 11-21-09. Retrieved April 8, 2009.
  6. ↑ Joe Neel and Joanne Silberner, "Stem Cells Used In Woman's Windpipe Transplant," All Things Considered, November 18, 2009, found at NPR story of 11-18-2008. Retrieved April 8, 2009.
  7. 1 2 3 EMBO, the European Molecular Biology Organization's official website. Accessed April 9, 2009.
  8. ↑ Raya, Angel; Belmonte, Juan Carlos Izpisúa (2009). "Stem Cell Research in Spain: If Only They Were Windmills …". Cell Stem Cell. 4 (6): 483–486. doi: 10.1016/j.stem.2009.05.016 . PMID   19497274.
  9. ↑ http://www.bionews.org.uk/page_11689.asp%5B%5D
  10. ↑ http://www.bionews.org.uk/page_12163.asp%5B%5D
  11. ↑ UK Government Press Release.
  12. ↑ The Guardian website
  13. ↑ 1998 (4) SA 113 (T), 1998 (11) BCLR 1434 (T).
  14. ↑ Jordaan DW (2007). "Science versus anti-science: the law on pre-embryo experimentation". South African Law Journal. 124 (3): 618–634.
  15. ↑ Cyranoski, David (2019-09-25). "The potent effects of Japan's stem-cell policies". Nature. 573 (7775): 482–485. Bibcode:2019Natur.573..482C. doi: 10.1038/d41586-019-02847-3 . PMID   31554988.
  16. ↑ "Iran in the forefront when it comes to stem cell research – CNN.com". CNN.
  17. ↑ "ISG-MIT website" (PDF). Archived from the original (PDF) on 2008-10-02. Retrieved 2009-04-14.
  18. ↑ Dajani, Rana (2014). "Jordan's stem-cell law can guide the Middle East". Nature. 510 (7504): 189. Bibcode:2014Natur.510..189D. doi: 10.1038/510189a . PMID   24919888.
  19. ↑ "Ministry to License JU Centre for Stem Cell Treatment". جريدة الغد (in Arabic). Retrieved 2017-04-10.
  20. 1 2 Christine Vestal, Staff Writer, Stateline.org, "Stem Cell Research at the Crossroads of Religion and Politics," Pew Forum paper, July 17, 2008, found at Pew Forum website. Accessed April 13, 2009.
  21. ↑ Obama overturns Bush policy on stem cells on CNN, Added April 14, 2009,
  22. 1 2 [ full citation needed ]
  23. 1 2 McMahon, E., Reguly, TA, "Follow–on biologics in Canada: A look at the new draft guidelines." Originally published in Update 2008, Issue 3, June 08, 2008, http://www.torys.com/Publications/Documents/Publication%20PDFs/AR2008-42.pdf
  24. ↑ "Where does New Zealand stand on permitting research on human embryos?". www.nzma.org.nz. New Zealand Medical Journal. Retrieved 2016-09-20.

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