Introduction
The current world is faced with a lot of health Challenges. New diseases are emerging while the already known ones are continuing to have negative impacts on people life. However, there are some light in the end of the tunnel. Over the recent years, researches on the use of Stem cells in treatment of diseases have shown very positive results (Smith, Neaves, & Teitelbaum, 2007). Recently, Company ABC was able to make major breakthrough in this field where it developed a gene therapy techniques to cure one of today’s health problem i.e. Zika virus. For this technique to be put in clinical use the company will need a large supply of Stem cells especially one extracted from human embryos as this one has proven to be more effective than those extracted from adults. However, the use of Human embryonic stems cell has attracted a lot of interest from not only biologists who discovered them but also from medical practitioner, policy maker, ethicists, religious leader and the society at a large. On one hand, they are those whose interest in the area is due to the potential clinical benefits it have as far a treatment of certain disabilities and diseases such as the Zika virus is concerned. On the other hand, they are those individuals whose interest on the area is purely based on ethicality and legality of research and potential clinical uses of human embryonic stem cells because for them to be extracted embryos which could have otherwise become human being are destroyed. Based on the above context, this report discusses the ethical and legal issues surrounding the use of stem cells in medical research and in clinical use. The report will also provide some recommendation to company ABC as far as their gene therapy techniques which uses stem cells is concerned.
Scientific background
By basic definition, Stem cells are those cells that have the capability of self-renewal as well differentiation into specialized cells type (Corrigan, Liddell, Macmilan, & Steward, 2006). Stem cells can be extracted from adults as well as Embryo. However, Stem cells founds in human embryo have found to be more capable of differentiating and renewal that those of extracted from adults.
Biologist and Researcher hopes that stems cells has the potential of being used to repair tissues and body organs as well as treat some of diseases. Therefore, recent research and therapies on stem cells are aiming to make breakthrough in this context
There are several ways in which biologist and researchers obtain Stem cells, first, they can use the excess embryo used IVF method, equally, stem cells can be extracted from embryo donate by donors. Alternatively, embryo can be create and stem cells extracted from them (Barfoot, 2013).
Ethical issues in stem cell research and therapies
The use of stems cells in research and therapies have elicited a lot of mixed reaction about their ethicality. These ethical issues are primarily based on the sources of the stem cells as well as the method used to obtain them. In regard to the source of stem cells, the cells can be extracted from adults as well as from embryos. However, most of biologists and medical practitioners are more attracted to embryonic stem cells when conducting research and therapies as cells from embryo are more effective in self-renewal and differentiation that those extracted from adults (Irish councils of bioethical, 2008). This however raises important ethical issues because for these types of stem cells to be extracted, embryos have to be destroyed. This has raised conflicting views and ethical standing among society. On one side of the views, there are those who beliefs that embryos are much of human being and therefore they have the right to life (Australia Stem cell Center, 2010). The people that hold these views argue that Embryo is an early stage of human development and if not tampered with, a human being will develop out of it (Nuffield Council on Bioethics, 2000). According to people who hold these views, the uses of embryonic stems cells in research and therapies is equivalent to killing a person in cool blood simply to extract their parts to be used to further self interest or gain. They argue that society has moral obligation of protecting the most vulnerable human being and there is no life that is more vulnerable than the one in the early stage i.e. embryo. They therefore feel that researches and therapies based on embryonic stem cells are totally unacceptable in the society if they are not for the benefits of the embryo itself (Corrigan, Liddell, Macmilan, & Steward, 2006).
Conversely, there are a numbers of people who support the uses of embryonic stem cells in research and therapies. These people have provided a numbers of reasons to support their argument. First they argue that embryo lack moral value as a human being since it is yet to be fully developed and it is therefore right to use them for research and therapies purpose (Lo & Parham, 2009). Secondly, there are those people who hold the views that the moral status of embryo is not the only ethical consideration that should be given priority. The society also has the obligation of alleviating the suffering of the already existing human being and therefore if embryonic stem cells have the potential to do so, there is morally supported ground to pursue it (Corrigan, Liddell, Macmilan, & Steward, 2006).
Legal issues in stem cell research and therapies
The legal Issues surrounding the uses of stem cells in research and therapies varies from one country to another. There are some countries that hold the views that the use of Stem cells has potential clinical benefits but have to be controlled. For instance, in UK, The human fertilization and embryology (HFE) Act was passed in 1990 which was later amended in 2001. The HFE Act make it legal to carry out embryonic stem cells research in UK, but the human embryo used must not be older that 14 days after fertilization. Initially, the HFE Act established the Human Fertilisation and Embryology Authority (HFEA) to license and approves all the researches that use Human embryo stem cells. Under this law, for one to be licensed and approved by the HFE authority, their research needed to meet the ‘specific purpose’ requirement. The Act stated that only researches that are done to improve the understanding and treatment of infertility and miscarriage or development of more effective contraceptives should be approved and licensed by the HSE authority. However, policy makers in the country believed that the ‘Specific purpose’ requirement as stipulated under the law were too narrow and as such amendment was introduced in 2001 to allows approval and licensing of embryonic stem cells who purpose is understand the development of embryo or treatment of serious diseases. Furthermore, the HFE Act also makes it legal to create embryo for research purpose only (Corrigan, Liddell, Macmilan, & Steward, 2006).
So, as for now the UK legal position as far as human embryonic stem cells based research are concerned is that such researches are legal and permissible but only if the human embryo used is not old that 14 days after fertilization and the research done meet the ‘specific purpose’ requirement i.e. it is either done to improve understanding of infertility and miscarriage, or to further development of contraceptive, or to understand development of human embryo or to understand treatment of serious diseases.
In the united state of America, there is no federal law that has ever ban the use of stem cells in research. However, different administrations that have assumed power had their own view and policy in regard to researches that use stem cells. During the George W. Bush administration, Stem cells research was no ban. However, the administration had introduced a policy that restricted the funding of stem cells research. According to this policy, the state was only allowed to fund research that uses Non-embryonic stem cells. All those researches that used embryonic stem cells were lefts out of state funding. However, the policy did not restrict private funding to such kind of research. When the new administration took the power i.e. the Obama administration, the use of Stem cells in research continued to be allowed. However, there was a major change in policy especially the one touching on funding. The administration removed all the restriction the previous administration had put in place in relation to state funding of research using stem cells. This new policy allows the state to fund both embryonic stem cell and non-embryonic stem cells researches (Barfoot, 2013).
Although there lack any federal law in USA that ban use of stem cells in research, different state have held different view on the matter. There are those states that are in support of stem cell based research while others are for their ban. For instance, the New Jersey in 2003 passed legislation that human cloning for the purpose of extraction of stem cells to be used in research. California is also in support of stem cells research. In 2004 it created a taxpayer-funded stem cell research institute (Barfoot, 2013).
On the other hand, they are those stated that has strictly restricted and also showed interest in banning stem cells research. For example, Michigan, North Dakota and others have already enacted state laws that make it illegal to creation and destruction of human embryo for research purposes (Barfoot, 2013).
In Australia, there are legislations governing the embryonic stem cells based research. In 2002, the country introduced its first ever legislation touching on embryonic stem cells research i.e. Human embryo Act 2002 and prohibition of human cloning Act 2002. The human Embryo Act 2002 made it legal to conduct research using embryonic stem cells research but only if excess IVF embryo are used. On the other hand, the prohibition of human cloning Act 2002 makes it illegal to use Embryo cloning for reproductive purpose as well as the use of somatic stem cell transfer method. These two legislations were later amended by the Prohibition of Human Cloning for Reproduction and the Regulation of Human Embryo Research Amendment Bill 2006. This amendment allowed the use of somatic stem cells transfer method to be used however one has to obtain a license to do so from the national health and medical research council (Australia Stem cell Center, 2010)
Some other countries such as Canada, Italy and Vatican with strong catholic tradition are more restrictive as far as the use of Use of stem cell in research and therapies is concerned. They hold the views that at this point in life the use of stem cells in research and therapies are not needed as it goes against majority’s belief about human life (Corrigan, Liddell, Macmilan, & Steward, 2006).
On the other hand, there are a number of countries especially those in Africa and Asia whose legislations has failed to keep up with technology changes and as such they lack any legislation touching on stem cell research and therapies. In this country, researches using stem cells are highly unrestricted and unregulated (Australia Stem cell Center, 2010).
Conclusion
The finding of this study has shown that despite stem cell research and therapies being a very promising field as far as treatment of disabilities and diseases are concerned, there are a numbers of ethical and legal issues arising. Ethical issues that arise are primarily based on the sources of stem cells. Most people beliefs that it is totally ethical to extract these cells from adult. However, the reaction is mixed in relation to extraction of embryonic stem cells. There are those who regard this as unethical because to them a potential life has to be terminated for the research to go on. However, there are those who hold the view that the destruction of embryo for research purpose is justifiable since any breakthrough will help alleviate suffering in already existing human being which are more important that the embryos itself as they have already develop unlike embryo which is in it early stage of development and it survival is therefore not guaranteed.
On the other hand, the legal position taken in relation to research and therapies using stem cells differs from one country to another. Some countries such as UK, Sweden, Greece, Belgium and Denmark and some states in America such as California and New Jersey hold the views that stem cells researches have potential clinical benefits. They however need to be regulated to ensure highest standard of ethics is maintained. On the other side there are other countries such as Australia, who partially support stem cell research. Conversely, there are another group of countries including Canada, Germany, Ireland and Italy, some states in America and some countries in Africa among other who have taken a very restrictive position as far as researches using stem cell research is concerned. Some such as Michigan state, has also ban or expressed interest to ban the use of stem cells especially embryonic stem cells in research.
Recommendation
Based on the context of the paper’s finding, a number of recommendations are provided in here to Company ABC in regard to the type of stem cells they should use, Ethical issues they should take into consideration when advancing their research and potential location where they can setup their stem cells laboratory.
Type of stem cells to should use The paper finding has showed that there are a number of ethical and legal issues touching on the type of cells used in research. While most people seems to have no objection to the uses of Non-embryonic stem cells in research, people ethical point of view in relation to embryonic stem cells is strongly divided in the middle. Those who object the use of embryonic stem cells do so because they considered Embryo as an early stage of life and to them life is sacred and should be protected. However, there are those who object embryonic stem cells because they beliefs that the possibility of research breakthrough is very minimal and therefore no justified reason to destroy embryo. However, biologist have indicated, embryonic stem cells are more effectives in differentiating and in self-renewal hence more effective in therapies that any other type of stem cells (Smith, Neaves, & Teitelbaum, 2007). Based on this context, this paper recommends that since embryonic stem cell has more capabilities in self-renewal and differentiation, company ABC Should use them in their research. However, to due to moral status attached to a very developed fetus, The Company should use those embryos that are less than 14 days old after fertilization. The use of these embryos would not only attract more support for the research but would also be in line with some of the legal framework such as those in UK. However, the company may also be regard as unethical by some people who hold beliefs that embryo is an early stage of life which must be respected. To avoid such criticism, the company should research on alternative methods of obtaining embryonic stem cells without necessaries destroying the embryos such as the “altered nuclear transfer” method (Coghlan, 2015) (Chung, 2005)which is at early stage of development.
Ethical issues to consider when advancing their research Due to the various ethical issues surrounding the stem cell research, there are a number of ethical considerations that company ABC should take into account when conducting it research.
First, they should consider the method they use to obtain stem cells especially embryonic stem cells. As mentioned in the paper, they are different ways in which embryonic stem cells can be obtained. It can be obtained from Excess IVF embryo or they can be created (Barfoot, 2013). Some countries prohibit creation of Embryo for research purpose and if that the case in country where Company ABC decides to conduct it researches it must desist from using this source or any other source prohibited by law. On the other hand, the use of Excess IVF embryo is mostly supported and ethically approved in most countries. However, if the company ABC decide to use embryo from excess IVF they;
- Will have to obtain written consent from the donors of the embryo.
- Must also maintain confidentiality of the donors.
As mentioned earlier, most of people especially the religious one beliefs that life begin at conception and therefore embryo have moral status as adult and it is therefore unethical to destroy them for research purpose (Hug, 2006; Irish councils of bioethical, 2008; Corrigan, Liddell, Macmilan, & Steward, 2006). This is an ethical issue that Company ABC should address when conducting it research. Where Possible, the company should find alternative ways of extracting embryonic stem cells without destructing embryos.
Location of their laboratories As indicated by the finding of these papers, the legal position in relation to embryonic stem cells research various from countries to countries or from state to state. Some countries are more supportive of the research other are partially supportive while others are very restrictive. This paper recommend that since company ABC is a multinational corporation, should not establish their research laboratories in countries or states with restrictive, partial support against stem cell research. The company should also not establish their laboratories in countries without any legal framework touching on Stem cell research since these countries are high risks for the company as such restrictive laws can be established at any time. The only option company ABC has is therefore to establish their laboratories in countries that fully support stem cells research. The country that fully support stem cell research are those that has stated clearly through legislation their support for stem cells research especially those done for development of treatment to serious disease. A country that also allows creation of embryo for research purpose would be most appropriate for company ABC. These company Include Britain, Denmark, Sweden, and some state in USA, South Africa, and Belgium among others.
