Stem Cell Legislation and the Related Legal Issues - Research Paper Example

?The isolation of human embryonic stem cells by Dr. James A. Thomson and its potential use in treating various diseases marked the beginning of the widely debated issue about stem cell research. Stem cells are totipotent in nature by which they have the ability to differentiate into any kind of human body cell such as blood cells to skin cells. Scientists are making strides to capitalize on this inherent nature of the stem cells to repair damaged tissues (AAAS Policy Research, 2010). However, despite the immense utility of stem cells, it is also been associated with several moral and ethical issues which has resulted in several country specific legislations and legal regulations both in the United States and several other countries which are involved in stem cell research (Dhar & John Hsi-en Ho, 2009). Embryo research in the United States has for long been linked with abortion as the Congress believed that promoting such research will encourage women to undergo abortions (Wertz, 2002). The human embryonic stem cells are the master cells of the body which have the potential to develop into any cell of the human body. These cells were first isolated in the year 1998 by researchers at the University of Wisconsin, under the guidance of Dr. Thomson, from the inner cell mass of the human embryo. Ever since researchers have focused on the ability of these stem cells to treat dysfunctional tissues by generation of new cells. With these cells scientists believe that several diseases such as Alzheimer’s, Parkinson’s, Diabetes, Multiple sclerosis and other nervous and metabolic conditions can be treated. This work by Dr. Thomson and his colleagues was not funded by the federal government’s primary sponsor for biomedical research, National Institute of Health (NIH) as the Congress had placed a ban on NIH- funded research on human embryo in the year 1995 and until 2001 there was no public funding for human embryo research. The ban prevented both the creation and the destruction of human embryos for research purposes. However, considering the potential of the discovery in 1998, the NIH appealed to the Department of Health and Human Services (HHS) about the funding for human embryonic stem cell (hESC) research. In 1999, the HHS concluded that public funding could be allowed for hESC research provided the derivation of these cells was carried out with private funds (Duffy, 2002). The moral and ethical issues associated with hESC research are related to the beginning of life following fertilization. While the people opposing the research believe that human life begins immediately after fertilization and not ant any specific stage of development and that the use of the human embryo is against the moral code (AAAS Policy Research, 2010). This also applies to the thousands of unused embryos in fertility clinics which are likely to be discarded. It is considered to possess an intrinsic value irrespective of whether it gives rise to a baby or not (Wertz, 2002). Those favoring the research have argued that only those embryos which implant in the uterus can be considered to be capable of giving rise to a human being. Using embryos which fail to implant or the excess embryos which are created in fertility clinics and left unused for research purposes would be morally fair rather than discarding them (AAAS Policy Research, 2010). The cultural factors that differentiate the views on embryo research between the United States and European nations includes: the government is answerable to the majority religiously fervent population as nearly 40% of the population attend church services, the politically active anti-abortion laws in the US and the inability to control the free enterprise of embryo research companies who are left to pursue their own goals (Wertz, 2002). The NIH draft guidelines released in 1999, during the Clinton presidency, allowed research on hESC from unused or leftover embryos in fertility clinics and those which were donated with the consent of the donor. The guidelines, which came into effect in 2000, faced mixed reviews from supporters and opponents of hESC research. But, the NIH received several grant applications for work with hESC and a committee was also established to review suitable proposals for approval. The encouragement for hESC research did not continue in the next government under President Bush as he vehemently opposed the use of embryonic stem cells for research. Thus after he became President, the NIH guidelines were withdrawn and ordered for a review in the issue. While several scientists, biotechnology companies and other organizations lobbied with the President to reintroduce the federal funding for hESC research, the Catholic Church and other anti-abortion groups resisted the move. In his response to federal funding on hESC research, President Bush declared in 2001, that the government would allow funding only for existing hESC cell lines thereby putting an end to all the speculation on the issue. He stated that as embryonic destruction had already occurred to create the existing cell lines, they could be used for research with federal funding but no further public funding would be allowed for creating new cell lines in the future. This decision, however, drew a mixed response with the proponents of hESC research arguing whether the existing cell lines would be sufficient to carry out enough research and those against the research both praised the president for limiting the research to existing cell lines and also criticized that no research should be allowed even with the existing cells. The decision by the Bush administration was based on reports that there were 64 cell lines in various laboratories across the world and it also released a report of 10 entities that created the cells lines and also announced the plan to create a stem cell registry by which information about those cell lines which were available for public funding would be provided. As a further step the President also announced the setting up of a President Council on Bioethics which will oversee all the ethical and legal issues related to stem cells and also the federally funded research on hESC. The NIH launched the Human Embryonic Stem Cell Registry in 2001 and by the year 2002, the registry listed 78 cell lines that were eligible for publicly funded research. However, the suitability of these cell lines for research use and also the delay in their availability for distribution to research institutes resulted in many experts calling for a reform of the President’s policy which was further supported by public pleas. Letters from 206 representatives and another from 58 senators requesting for leniency on the stem cell issue were handed over to the President. With the support of nearly 189 bipartisan house members the legislation H.R 4682, the Stem Cell Research Enhancement Act of 2004 was introduced which called for the need of increasing federal funding for stem cell research and also to allow the use of embryos donated from IVF clinics for deriving stem cells. This bill was rested. As another move to promote stem cell research the NIH in 2004 announced plans for setting up a stem cell bank by which the available stem cell lines would be consolidated to one location. The reintroduction of the Stem Cell Research Enhancement Act H.R. 810 in the year 2005 saw favorable gains as it was passed by the house with a bipartisan vote of 238-194. Following this the bill was also passed in the Senate with a vote of 63-37 along with two other bills, S.2754 which called for research methods for obtaining cells similar to hESC and S.3504 which prohibited the establishment of fetal farms. The bills were then placed in the suspension calendar, which is a speedy voting process, in which only S. 3504 was passed and the President subsequently passed S.3504 and vetoed H.R.810. However, following this lag in hESC research several states such as Florida and California took up the cause and initiated their own funding for hESC research. The S.5 bill which was again passed in the Senate in 2007 was also vetoed by President Bush. The Obama government pledged support to increase federal funding for stem cell research and when he took office, President Obama issued an executive order by which guidelines for expanding the existing stem cells lines were to be framed within 120 days. In addition, the Stem Cell Research Enhancement Act and another new bill, Stem Cell Research Improvement Act was also introduced again. In 2009, the NIH published a new set of guidelines which allowed federal funds for the use of donated leftover embryos in fertility clinics for research but only after an informed consent was obtained from the donors. It would also continue to fund research on adult stem cells. However, it maintained that funding will not be provided for research using embryos created specifically for research purposes or stem cells obtained by cloning or parthenogenesis. In a further set of guidelines the NIH decided that the quality and use of the older stem cell lines will be evaluated by an NIH advisory panel. According to the Dickey-Wicker amendment no federal funding would be provided for research that creates or destroys a human embryo. In 2010, a preliminary injunction for the NIH funding of hESC research was issued based on two lawsuits that were filed by scientists from Boston and Seattle who claimed that such funding would cause them irreparable injury as they are likely to prevent funding for their adult stem cell research work. The injunction was later temporarily stayed in order to hear the oral arguments, following which a three-member judge panel ruled in favor of continuation of federal funds for hESC research (AAAS Policy Research, 2010). Thus as a result of several ethical and cultural views there is no specific policy or rules that govern stem cell research. Hence every country has developed their own policies and guidelines for the use of stem cells in research. Among the Asiatic countries, China prohibits human reproductive cloning while allowing the creation of human embryos for therapy. The government allows researchers to carry out stem cell therapy for chronically and terminally ill patients. In China the stem cell policies are unrestrictive as they allow leftover embryos in IVF clinics, fetal cells obtained from abortions and from blastocysts. The Japanese government allows stem cell research though no formal guidelines are followed. The Policy of the Council for Science and Technology allows stem cell research for therapeutic purposes. Singapore, which harbors more than 40 stem cell groups, has authorized the use of embryos which are less than 2 weeks old. India has created several stem cell banks which store embryonic stem cells for future therapeutic use. While it has banned reproductive cloning, therapeutic cloning is permitted. Guidelines for stem cell research have also been issued by the Indian Council for Medical Research. While Australia has banned all human cloning experiments, leftover embryos in IVF facilities can be used for research. South Africa bans reproductive cloning while therapeutic cloning is allowed and is the first African nation to start a stem cell bank. Among the European countries, Belgium has banned reproductive cloning but has allowed therapeutic cloning of embryos. France both prohibits reproductive cloning as well as the creation of embryos for research. But a legislation passed in 2004 has allowed the use of excess embryos from fertility clinics for research and another guideline in 2006 allowed scientists to create their own cell lines from these embryos. The German law is restrictive towards stem cell research and bans the creation of embryonic stem cells. Only imported stem cells lines can be used for stem cell research and therapy purposes. Italy also has strict embryonic stem cell research limitations as the law prohibits donation of sperms and eggs and also the freezing of embryos. However, research on imported stem cell lines is permitted. Spain has legalized therapeutic cloning and also has established a stem cell bank and centers that are involved in stem cell research. Therapeutic cloning is supported by the Swedish government, in addition to setting up a stem cell bank. According to the Human Fertilization and Embryology Act in the UK embryos can be destroyed for deriving embryonic stem cells provided the research proposes to use the stem cells for developing potential treatments for diseases or uses it to study the development of embryos. Embryos remaining after assisted reproductive facilities are allowed for research in Switzerland. The Brazilian government allows the use of excess embryos in fertility clinics that have been stored for more than 3 years despite the Catholic Church challenging the law. The stem cell laws in Mexico are not subject to any regulations and doctors have been using stem cells to treat ailments such as cerebral palsy and autism. Canada allows the use of discarded embryos from fertility clinics for use in research but prohibits the creation of embryos (Dhar & John Hsi-en Ho, 2009; Ralston, 2008). Middle Eastern countries such as Israel have also made several important contributions to stem cell research beginning with the extraction of stem cells from blood. Stem cell research in this country focuses on its use in regenerative medicine and treatment for diseases such as diabetes. Even in Saudi Arabia a fatwa issued in 2003 allows the use of embryos for therapeutic and research purposes (Ralston, 2008). Reference 1. AAAS Policy Research: Stem Cell Research. (2010). Aaas.org. Retrieved 9 June, 2011, from http://www.aaas.org/spp/cstc/briefs/stemcells/ 2. Dhar. D & John Hsi-en Ho. (2009). Stem Cell Research Policies around the world. Yale Journal of Biology and Medicine, 82(3): 113-115. Retrieved 9 June, 2011, from http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2744936/ 3. Duffy, D.T. (2002). Background and Legal Issues Related to Stem Cell Research. Policyalmanac.org. Retrieved 9 June, 2011, from http://www.policyalmanac.org/health/archive/crs_stem_cell.shtml 4. Ralston, M. (2008). Stem Cell Research Around the World. Pewforum.org. Retrieved 9 June, 2011, from http://pewforum.org/Science-and-Bioethics/Stem-Cell-Research-Around-the-World.aspx 5. Wertz, D.C. (2002). Embryo and stem cell research in the United States: history and politics, Gene Therapy, 9(11): 674-678. Retrieved 9 June, 2011, from http://www.nature.com/gt/journal/v9/n11/full/3301744a.html Read More