Introduction:
Assisted Reproductive Technologies (ART) such as surrogacy, artificial insemination, in vitro fertilization have immerged as a blessing for the couples facing infertility. ART can be defined as any other medical technique which is used in an attempt to obtain pregnancy by any other means other than intercourse. In this method, the ovaries and sperms are manipulated outside the body and in the uterus, the gamete of the embryo is transferred.
According to Assisted Reproductive Technologies Act- (Regulation) Bill 2010, ART can be defined as:
“All techniques that attempt to obtain a pregnancy by handling or manipulating the sperm or the oocyte outside the human body and transferring the gamete or the embryo into the reproductive tract”.[1]
In-Vitro Fertilization is the widely used technique under over the world under Assisted Reproductive Technologies.
In Vitro Fertilization
In-Vitro Fertilization, commonly called IVF or test-tube baby, is a procedure much opted by the infertile couple. In this method, outside the body, the fertilization of an ovum takes place after which embryo, also known as blastocyst[2] is consequently transferred into the woman’s uterus. The “In Vitro” is a Latin word which means “in glass”. It is referred to as a test tube but this term is used for laboratory procedures generically. The process can be defined as:
“It is a laboratory procedure in which sperm are put in a special dish with unfertilized eggs to achieve fertilization. The embryos that result can be transferred into the uterus or frozen (cryopreserved) for future use”.[3] This process is a complex procedure that helps to tackle the issues of fertility and prevent genetic problems.
The success rate is 20-30% for each IVF cycle. Factors that affect the success rates include the quality of sperm and egg, age of the patient, medical expertise, reproductive health and infertility duration. The major complication involved in IVF is the risk of multiple births because of the transfer of multiple embryos. In IVF, the third party such as a donor or a surrogate mother can also be involved.
This type of fertilization is done in the five types of cases. First one is when fallopian tubes of the women are blocked. The second case is when there are ovulation problems. The third case is when a man has seminal problems of mild degree. The fourth case is if there are any seminal antibodies present in the woman’s body. The last one is the cases of unexplained fertility.
The process of IVF involves a four-stage procedure. They are ovary stimulation, egg retrieval, fertilization and embryo transfer. There are also other techniques which may be used in the process of IVF that helps in improving the success rate and the quality of the method such as Intracytoplasmic Sperm Injection, Zygote Intrafallopian Transfer, Preimplantation Genetic Diagnosis, Autologous Endometrial Co-culture, Testicular Sperm Extraction, Gamete Donation and Surrogacy.
History of In Vitro Fertilization
The technique of in Vitro Fertilization was developed by Doctors Robert Edwards and Patrick Steptoe in the United Kingdom. The first known test tube baby named Louise Brown[4] was born on July 25 1978, in the middle of the intense controversy involving the morality and the safety of the procedure.
In India, the first time IVF was used was to produce a test tube baby named “Durga”[5] which also became the second test-tube baby in the world. It was performed by Dr Subhash Mukhopadhyay who is a Calcutta based doctor and it was performed on 3rd October 1978. These events became a public debate, a topic for criticism and also a target of social professional ostracism because of the involvement of initiation of a life outside of woman’s body. But even after these obstacles, IVF’s technique has survived by becoming a choice for treating infertility in some way.
Legal and Ethical Issues Concerning In–Vitro Fertilization
The existence and rise in the popularity of these technologies gave rise to many legal and ethical issues. Eligibility to access IVF, eligibility to donate the gametes and in the case where there are preserved embryos, the legal status of that embryo are the issues faced by our present legal system. Other issues such as the question of IVF baby’s parentage and inheritance are also important issues.
In the early times, this concept of IVF was made to help the infertile couples. It is to have a kid but nowadays where the homosexual couples. Also single people are approaching for IVF, the question of their eligibility also arises that; whether they should be allowed to have a kid through IVF or not. But if we prohibit them from taking the help of IVF, then it would be a violation of their basic human right that is to form a family and in some countries, it is the violation of their constitutional right i.e., right to procreate.
The idea of the child to be brought of in a traditional, stable and friendly family is of the utmost interest. Also the parents should have a sufficient sense of responsibility. But there is the guarantee of a couple with the opposite sex to give such environment to the kid. So the family structure is unpredictable; when it comes to the quality of the parenting. Therefore is an inadequate measure for outcome environment of the child. The family in any form has variations in their level of functioning so deciding the future of the children; on the sexuality of the parents. The form as in gas, lesbian or gay couple is a vague measure.
Chief Commissioner of Families Commission of New Zealand held that “Children are better off with two parents committed to each other. We don’t dispute that. But there are a good number of two-parent families making a mess of it and there are a number of single-parent families doing exceptionally well. Whatever the family is, it needs to be supported.”[6]
A country like India which allows adoption for single parent irrespective of the gender that avoids the need for the presence of both the parents, therefore opposing a single parent for IVF is not tenable.
United State has no federal regulation for ART but some states have legislation regulating ART while New Hampshire restricts explicitly the access the procedures relating to ART. Only the woman above 21 years of age and who has been medically evaluated in addition to the counselling being received by them.[7] Even some states only allow married women to go for ART. Canada has Assisted Human Reproduction Act, 2004. There are other regulations followed by different countries in this aspect.
In India, there is no statute that governs the issues that are related to the donation of gamete. But if we consider the selling or buying of the gamete, it’ll be against human life dignity. From the countries like US, UK, Israel etc., the fertility clinics are turning to India for the search of the ovum and this is why India is becoming a centre for the outsourcing of biological process. This is because by donating the ovum, that person is paid some amount of money[8].
This programme in India is gaining the popularity only because of the absence of any law to regulate ART clinics that are involved in the transaction and thus it can’t be prohibited. In India, there are guidelines laid down by the Indian Council of Medical Research which provides for the donors of gametes for being compensated appropriately.[9] And they have also recommended for the prohibition of purchase and sale of embryo and gametes.[10]
In the case of the donation of gametes, ICMR prohibits the donation by a friend or a relative of the couple that seeks treatment[11] as because of the presence of personal laws which prohibits the marriage in certain relation and donation of the gamete from such a person raise controversial issues. Also, the rights and duties of the donor of the gametes should be defined by the statue in order to avoid any future controversies.
When parentage of the child born through test tube comes into question, there is an absence of laws in India to confer the legitimacy of the child. Therefore, by establishing a contract between the donor and the donee only, can the issue be resolved.
ICMR Guidelines and Assisted Reproductive Technology (Regulation) Bill
Clinics for ART in India provide a requisite technology and also personal care at a lower rate as compared to those outside the country. But the treatment concerning IVF comes under the legal gamete of ICMR. The legalities help us to identify a better clinic for the treatment. There is a criteria defined by ICMR which fertility clinics with legitimate status need to fulfil. They are as following:
- Fertility clinics that are involved in infertility treatments and the creation and use of the embryos need to have registration.
- For the identification of the qualification of personnel, a code of practice is required.
- Without the written consent of the couple, the treatment can’t take place.
- Information and counselling should be given to the couples regarding the treatment before and also during the process.
- A human embryo is prohibited to be placed in a non-human body and also the research projects need to be approved by the Institutional Ethics Committee. [12]
In 2002, ICMR drafted national guidelines for the Indian ART clinics because as the clinics emerged, a need for regulatory and supervisory body and the control of Government was felt. These guidelines were later examined by the Ministry of Health & Family Welfare and published in 2005 as “National Guidelines of Government of India”.
In 2008, ICMR developed a draft for “Assisted Reproduction Technology (Regulation) Bill” and sent to the Ministry of Health & Family Welfare which was revised by the Ministry as “Assisted Reproductive Technology (Regulation) Bill-2013” and after that “Assisted Reproductive Technology (Regulation) Bill-2014” was also presented before the Cabinet which proposes for the establishment of National Registry and Board at both National and State level for the supervision over ART clinics and banks in order to ensure that the services provided by them are ethical and the social, medical and legal rights of the parties concerned are protected at maximum within a defined framework of ethical and good medical services. In 2020, ART Regulation Bill is also presented before the Cabinet which proposes the same thing as Bill of 2014 along with making the Pre-Genetic Implantation Testing compulsory.
It also proposes for the doctors to be allowed to test the embryos for the presence of any abnormal chromosomes and the egg donor to be supported by the insurance cover is mandatory. It also mentions about the rights of the baby through ART same as biological children and stringent punishment for those involved in sex selection or agencies involved in such unlawful practices including the sale of gametes or embryos. Also includes a fine for those who are involved in trafficking and transaction of embryos at first instance and imprisonment for 12 years at the second instance.
Conclusion
Currently, in India, there is no legislation regulating In-Vitro Fertilization and Assisted Reproduction Technology. Therefore only through the legislation can the legality of In-Vitro Fertilization can be defined. Now there is no statute available which leads to illegal instances occur in India. The guidelines by the Indian Council for Medical Research are only recommendatory. The development in biotechnology fields requires strict regulation and statutory body for the monitoring.
Because of the existence of different personal laws and restriction by those laws such as marriage prohibition in certain relations raises controversial issues before the framers of laws and this can only e resolved by proper legislation and by the necessary amendments in some personal laws by making it in consonance with advanced technologies. The legislation should also consider the homosexual couples and single male or female as they also have the basic human right to have a family but it should be made by keeping the interest of the children at utmost interest.
References:
[1] Section 2 (c) , The Assisted Reproductive Technologies Act- (Regulation) Bill 2010.
[2] http.//www.search.eb.com/eb/article-9042232.
[3]William C. Shiel Jr., “Medical Definition of In vitro fertilization”, https://www.medicinenet.com/script/main/art.asp?articlekey=7298 (last visited Feb. 22,2020, 3.50 p.m.).
[4]Available at http://www.legalserviceindia.com/articles/art_ins.htm.
[5] Law Commission of India, Report No. 228, August 2009.
[6] M. Hoghughi and N. Long, Handbook of Parenting : Theory and Research for Practice, SAGE Publications, London, 2004, p.l 10.
[7] http://www.law.reform.vic.gov.au/.
[8] http://timesofindia.indiatmes.com/cms.dll/htm/uncomp/articeleshow.
[9] Rita L. Bender, Raegen N. Rasnic and Janet M. Helson, Legal Issues of Surrogacy, Artificial Insemination, Egg Donation and Embryo Donation, A v a ila b le a t http://www.skellegerbender.com/publications/PDFs/adoptionreproduction/surrogacy.embryo.pdf.
[10] National Guidelines for Accreditation, Supervision and Regulation of ART Clinics in India, Section3.91 and 3.92, Available at http://www.icmr.nic.in/art/clinics.htm .
[11] Ibid.
[12] Available at https://www.theindusparent.com/infertility-in-your-30s.
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