Legal Issues of in-Vitro and Donor Technology, Research Paper Example

Introduction

The emerging regulations and changes in health care law implicate that the legal background of donor technology, protection and data protection are becoming one of the focal points of decision-making agencies. The below paper is designed to review the existing legislation, related regulations and new initiatives covering in-vitro procedures and donor technologies, in particular the use of samples, donor and recipient details, as well as the protection of individuals’ rights. While success rates still vary from one institution to another, there is an increasing amount of criticism that surrounds in-vitro fertilization and donor technology. The criticism of legislation, policies, institutional procedures, compliance and legal requirements will be reviewed in the current paper, based on the available legislation documents, historical cases and research. The main thesis question is whether the regulations covering donor and in-vitro biotechnology provide adequate protection for patients, donors and other parties involved in research and procedures.

Historical Context

The first “test tube” baby was generated in England back in 1978. Since then, donor technology and in-vitro fertilization has become a common procedure all around the world. (Coutts 1) The question of in-vitro fertilization when two traditional partners (husband and wife) are involved is not complicated from the legal and ethical aspects. However, recently the number of cases when third party, unknown to the couple before got involved in the procedure has increased in the past years. No matter if the donor is recruited by a fertility clinic or is a private donor through a sperm donation service, the interests of the couple, embryo and the donor need to be protected equally. As same-sex and non-traditional relationships are becoming more common in the United States, the right of gay and lesbian couples for children, as well as the definition of a traditional family life needs to be looked at by legislators and policy-makers.

As in-vitro fertilization is extremely expensive (Coutts 2), a treatment costing about 5000 dollars, it is important to determine the priorities and criteria for making decisions regarding the person receiving the treatment. Coutts (2) also confirms that in five US states, health insurance companies need to pay the cost of infertility treatment, and although IVF is still considered an experimental procedure, many people are not covered. This also indicates that having children despite fertility problems is determined by the couple’s economic status and paying abilities.

The IVF Worldwide (online) summarizes the main milestones of IVF treatment technologies, identifying the issues related to each change and procedure developed. One of the main steps forward detailed in the summary is the use first use of donor eggs in 1983. This procedure made it possible for a woman without ovaries to have a child. In 1984, the first pregnancies related to frozen embryos were reported. Later, several new procedures were creates, such as sperm retrieval through operation, ovarian tissue transplants, in vitro maturation and genetic modifications of zygotes. Reproductive tissue transplant has developed extremely fast, according to Blake (354) and brought several ethical and legal challenges to deal with. The research achievements were so many that the legislation surrounding them was not always up to date, creating ethical and legal dilemmas in several cases. The next part of the research will detail some of the relevant legislation and ethical issues.

Related Legislation

Informed Consent and Women’s Rights. According to Laufer-Ukeles (567) the interest of the fetus and the reproductive choices of women need to be harmonized by the legal system. Research is strictly regulated in the United States, however, in many cases, informed consent is only required for research and not experimental procedures. Further, the author also states that there are several shortcomings in the legal system regarding women’s autonomy regarding reproductive health. While the choices for contraception, treatments and interventions are highly regulated by health care law, the medical interest of different parties still crash, creating a legal issue. Laufer-Ukeles calls for a framework to increase women’s autonomy, while taking into consideration the interdependent relationship of the mother and fetus. The only protection available within the current system is the informed consent, designed to protect the autonomy of patients. (569) Providing information for patients before any medical intervention is described as an obligation within the US legal system. Regarding to bioethics, it has a purpose of covering four different areas: the competency of patient to make a decision regarding their health, consent to the option offered, the statement of voluntary decision-making and provisions for adequate information.

The choice to undergo fertility treatment is less regulated than contraception and the termination of pregnancy by the constitution. (Laufer-Ukeles 574) Some acts cover the treatments and options, such as the Fertility Clinic Success Rate and Certification Act, regulating the success rates required by clinics to carry out treatments. Still, the major problem the author identifies is the “lack of alignment among doctor, state, and patient due to fetal interest”. (579)

Non-Traditional Kinship and Legal Issues. Roselblum (18) talks about unsex mothering and the question of non-traditional parenthood. It is important to note that the Uniform Parentage Act has a gender-specific language and does relate to traditional couples’ IVF treatments. However, recent martial and family law developments have resulted in a demand from same-sex couples to have a child. The technologies are in place, however, the legal background is not clarified so far. A new culture of parenting is developing, and decision-makers have to deal with the emerging trends. Gender equality needs to be implemented in every area of the legal system, including family law, based on a term determined by Rosenblum (20) as sex neutrality. The term describes an objective that provides equal opportunities to become a parent for all sexes and is aimed at diminishing discrimination. While there are several organizations opposing the idea that same sex couples should have children, the legal rights of all citizens should be protected equally. What Roselblum describes as “biology’s outsized role” has several social and legal implications. Unsex parenting is already built inside the United States’ Family and Medical Leave Act, which permits mothers and fathers to take leave and look after the family. The Act does not only relate to women. The language of the Act is also sex-neutral, it does not fully acknowledge the changing gender roles in the American society. (57) While the author mainly describes the problem from ethical and sociological perspectives, it is evident that the legal system needs to deal with the question of unconventional relationships and assisted reproduction techniques, like semen treatments. (Lewis 237)

Children of Assisted Reproduction and Inheritance. One of the least obvious implication of IVF and donor technologies is the uncleared legal status of children born through assisted reproduction. Knaplund (899) confirms that the US succession law needs to be reviewed in the light of the new biotechnological developments. While the first in-vitro baby was born more than thirty years ago, the legal system of many states in the United States are ineffective regarding the clarification of children’s family status and establishing parentage. The Uniform Parentage Act (UPA) is only implemented in a few states, and many provisions to protect the rights of children and parents are absent. If even basic legislation cannot be clarified, the question of children born years after their father passed away or who were born through gestational carriers. (899) The author quotes Section 2-120 of the Family Law, related to parent-child relationship. The question is simple when there is no donor or gestational carrier involved. When, however, a child is born through one of the assisted reproduction techniques, (ART), and the intended parents are not the same as the genetic mother or father, the law needs to declare that the father providing the sperm or the mother donating the eggs is a “third party donor”. (899)

Postmortem conception is another problematic area of legally determining parentage. The legal situation is different if the gametes were implanted before the death of the father or after. There is a need for written consent for determining the biological or intended father as a legal parent.

The question of parent-child relationship is also problematic when a child is born to a gestational carrier. While the initial intentions of the woman (carrier) are not to become a parent legally, there is often need for parental agreement. Establishing consent is the only way to guarantee the legal parentage of the intended mother. While a gestational carrier agreement is usually obtained, its enforceability is different within the Uniform Probate Code and the Uniform Parentage Act. While the amendments of the UPA (2002) and the UPC (2008) provide some provisions for the legal status of children born through ART, these policies are not fully implemented in all states, creating uncertainty regarding parent-child relationship.

Forman (57) confirms that the question of divorce and separation is not covered by legal system, either. The author states that clinical consent forms do not provide enough protection for parties, therefore, there is a need for developing new legal approaches. Clinics often ask for the signed cryopservation agreement (58), however, these agreements do not provide legal settlement for parents. As the content of the forms differs, as well as the requirements by state, the disputes become complicated when it comes to divorce. If the agreement does not provide a suitable framework, there is a need for developing one. Courts can indeed still rule for embryo disposition during divorce procedures. This has its ethical and legal implications: disposing of an embryo is considered a murder by some religious people, while the rights of a mother to a child are affected.

The Regulation of the Private Sperm Donation and Surrogacy Market – A Loophole? Acker (1) calls for a legislative step to regulate the unregulated private sperm donation market. The author draws a contrast between the donation that goes through a clinic and the “private” methods, stating that the lack of regulation causes confusion regarding parental rights. The legal system does not prohibit seeking “privately donated sperm” (2), while there are several risks associated with this procedure. As there are no genetic tests carried out by the clinic, there is an increased chance for the baby inheriting diseases, sexually transmitted illnesses or mistakes can be made by the sperm bank. There are, according to Acker (2) risks associated with institutionalized and private sperm donation alike. However, she concludes that private donations are more likely to be self-regulated and parties can make an arrangement regarding parental rights. Still, the question of avoiding sexually transmitted diseases remains open. Quoting the The American Society of Reproductive Medicine (ASRM) and the American Association of Tissue Banks (AATB) non-mandatory guidelines, the author states that by complying with the above recommendations, private sperm donation can be made safer without legislative intervention. (Carroll 88)

Luckey (213) talks about the lack of regulation within the surrogate “market”. The basis of the debate is mainly ethical: should surrogate services be allowed to be commercialized? If yes, they need to be treated as a separate industry and compliance requirements need to be set for it. While in many cases surrogacy is covered by a written agreement, there are still several risks associated with the service. Reviewing the domestic uniform regulation, the related chapters of the Uniform Parentage Act and the Uniform State Law updates clarify the issue the following way: “gestational agreement is enforceable only if validated as provided in Section 803.” (Quoted in Luckley, 237)

Frozen Embryo Disposition. One of the most debated questions in US courts regarding assisted reproduction techniques is related to previous agreements regarding frozen embryo disposition. Myott (620) talks about the discrepancies among courts related to decisions. Every court takes a different approach, as there is no adequate regulation. Still, according to the author, none of the decisions were able to successfully resolve the constitutional dilemma related to the protection of parties’ rights. (Margalit 356)

If there is no previous agreement before the IVF takes place on how to use and dispose of embryos, it is likely that there will be a legal dispute in the future, according to the author. The legal system classifies embryos three different ways: person, a property or something that is neither a person nor a property, but has the potential of becoming a human. (Myott 620) There are only a few cases within the United States where the legal system addresses the question of embryo disposition. Still, the legislation is far from being homogenous. In Louisiana, for example, an embryo is defined as a person. In Florida, however, the legal system requires couples to cover the eventuality of embryo disposition in an agreement in case a decision is needed in a divorce case. (Strasser, 31)

Related Cases Reviewed

As there are gaps within the regulation of IVF and donor technologies, according to Acker, the most effective way of testing approaches is using lawsuits as guidance for different cases. The author describes lawsuits as “potential avenues” (33). Quoting one of the cases in California (Johnson v. Superior Court of Los Angeles County), she describes the decision as one that can act as a precedent for the rule. A sperm bank was, in this case, aware of the genetic disorder of the donor, however, they still accepted him for sperm donation. The receiving woman was hence not informed of the fact. The defense stated that the sperm was screened before it was provided for the woman.

The most commonly discussed case regarding ART is the one concerning the Capato family (Astrue v. Capato) detailed from a legal perspective by Barzilay (2). The father was diagnosed with cancer and was told that he would soon become sterile as a result of impending chemotherapy. Nick (the husband) deposited sperm in one of the banks, but the couple was able to have one child in a natural way. After Nick passed away, the wife underwent fertility treatment and managed to conceive. Only one child of the twin birth survived, however, Karen applied for insurance benefits based on her late husband’s earning records, based on the Social Security Act. The claim was first rejected by the Social Security Administration, quoting § 416, which indicated that the twins were not heirs or beneficiaries. Karen appealed and asked the court to accept her twins as “children” in legal terms. The Supreme Court, reviewing the related regulations also concluded that the children conceived after the father’s death, not named in his will were not legally the children of Nick. The above example shows that there is indeed a need for clarifying the question of fatherhood, frozen cells, sperm and agreements made regarding the status of embryo and babies born through ART.

Findings

States’ Challenges of Regulating Legal Status of Embryos. Reich and Swink (2) predict that states will have increased challenges with regulating the legal status of embryos and the increased need for in-vitro fertilization does also mean that the legislators will have to deal with an elevated number of and significantly more diverse cases.

The American College of Obstetricians and Gynecologists (4) created a study reviewing the legal and ethical issues regarding in human in vitro fertilization. They researched the legislation and ethical considerations, finding that the participation of husband and wife in the procedure was both ethical and legally covered. The committee, however, found the question of frozen eggs and embryos, as well as the number of eggs to be fertilized legally complicated.

Implications

The research of reproductive health has been covered in many aspects by researchers recently, however, as the above research has shown, there are legal, ethical and financial considerations to be looked at in the case of in-vitro and donor technology. As the methods and procedures change with the advancement of research, it is time to create an interdisciplinary approach to fully reveal the current regulation of biotechnology and the way forward.

Roberts (771) talks about gender inequality in making decisions about reproductive health and fertility preservation. This is another issue that needs to be addressed by future legislation. The author also talks about economic inequality; an issue which has already been covered in this paper. The cost of contraception, sexual health, IVF and donor cells indicates that those from a lower socio-economic background will be disadvantaged. Still, the society’s inequalities cannot fully be addressed by legislation.

Conclusion

The above review of legislation above In-vitro fertilization and donor technologies has revealed several discrepancies and unexplored areas in the legal system. These will be listed below in order to review the findings of the above literature research.

1. The modifications of the Uniform Parentage Act and the Uniform Probate Code are effective in addressing the legal status of babies born through in-vitro and assisted fertilization, however, there are new, emerging unique cases to be dealt with by the law.
2. Reviewing individual court cases is an effective way of creating new legislation from precedents.
3. The lack of regulating private donor services imposes a great risk on patients and donors alike. Some issues regarding compliance and ethics need to be addressed by law.
4. The right of non-traditional couples to ART needs to be regulated according to non-discrimination guidelines.
5. The legal status of Embryo might need to be standardized through the states in order to avoid discrepancies.

As a conclusion and an answer to the original research question, it has been revealed through the research that states and the federal government are working on changing the legislation surrounding ART, however, without the review of individual cases and taking into consideration their unique characteristics, donor and in-vitro technology will always be steps ahead of the legislative process.

Works Cited

Acker, Jacqueline. The Case For An Unregulated Private Sperm Donation Market. UCLA Women’s Law Journal. 20. 2013. Web.

American College of Obstetricians and Gynecologists. Ethical Issues in Human in Vitro Fertilization and Embryo Placement, Committee Statement. July 1986. 4 p. ACOG, Print. D.C. 20024, 202-638-5577.

Astrue v. Capato. Oral argument: Mar. 19, 2012 Legal Information Institute. Web.

Barzilay, Arianne Renan. You’re on Your Own, Baby: Reflections on Capato’s Legacy. Indiana Law Review. 46 Ind. L. Rev. 557. 2013. Web.

Blake, Valerie. Ovaries, Testicles, And Uteruses, Oh My! Regulating Reproductive Tissue Transplants. William & Mary Journal of Women and the Law. 19. 2013. Web.

Coutts, C. Ethical Issues in In Vitro Fertilization. National Reference Center for Bioethics Literature The Joseph and Rose Kennedy Institute of Ethics. Scope Note. 1988. Web.

Carroll, Andrea. Roundtable on Regulating Assisted Reproductive Technology 2012: Discrimination in Baby Making: The Unconstitutional Treatment of Prospective Parents Through Surrogacy. Indiana Law Journal Fall, 2013. Web.

Forman, Deborah. Embryo Disposition and Divorce: Why Clinic Consent Forms Are Not the Answer. Journal of the American Academy of Matrimonial Lawyers. 2011. Web.

IVF Worldwide. IVF History. (n.d.) Web.

Johnson v. Superior Court of Los Angeles County. Justia US Law. Case Description. Web.

Knaplund, K. Children Of Assisted Reproduction. Symposium: The Uniform Probate Code: Remaking American Succession Law: Article. University of Michigan Journal of Law Reform. 2012. Web.

Laufer-Ukeles, Pamela. Reproductive Choices and Informed Consent: Fetal Interests, Women’s Identity, and Relational Autonomy. American Journal of Law & Medicine. 2011. Web.

Lewis, Myrisha. Sex And Statutory Uniformity: Harmonizing The Legal Treatment Of Semen. Charleston Law Review. Winter, 2012-2013 2013. Web.

Luckley, Cara. Commercial Surrogacy: Is Regulation Necessary To Manage The Industry? Wisconsin Journal of Law, Gender & Society. Fall. 2011. Web.

Margalit, Yehezkel. To Be Or Not To Be (A Parent)? – Not Precisely The Question: The Frozen Embryo Dispute. Cardozo Journal of Law & Gender. 18. 375. 2012. Web.

Myott, Mark. Neutral Grounds Revisiting the Current Legal Approaches in Frozen Embryo Disposition Disputes Through the Lens of Neutrality. Georgetown Journal of Law & Public Policy. 619. Web.

Reich, J. B, and Swink, Dawn. Outsourcing Human Reproduction: Embryos & Surrogacy Services In The Cyberprocreation Era. Journal Of Health Care Law & Policy. 2011. Web.

Roberts, Dorothy. Changing Conceptions: Exploring The Medical And Legal Advances In Fertility Preservation: Twenty-First Annual Law Review Symposium: Article: The Social Context Of Oncofertility. DePaul Law Review. Spring, 2012. Web.

Roselblum, Darren. Unsex Mothering: Toward A New Culture Of Parenting. Harvard Journal of Law & Gender. 2012. Web.

Strasser, Mark, The Next Battleground? Personhood, Privacy, And Assisted Reproductive Technologies. Oklahoma Law Review. 177. Web