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Examination of In Vitro Fertilization (IVF) and its legal perspective

Assisted reproductive technology means any medical technique that attempts to obtain a pregnancy by means other than intercourse. This manipulates the sperm and oocytes outside the body and the gamete of an embryo are transferred into the uterus.

In vitro fertilization or IVF is commonly called a procedure sought by the infertile couple. Normally, fertilization occurs within the fallopian tube which joins the uterus to the ovary. Whereas in an IVF procedure, the sperm and the eggs of a desiring couple are collected and then the fertilization is done in the laboratories.

Through this process, the ripe egg is taken out from the women�s body and then that egg is combined with sperm in a petri dish. This process is commonly known as �laparoscopy� or �aspiration�. After this, the embryo is implanted in the uterus to continue growth if the fertilization occurs. Those children�s who are conceived through this method are called �test-tube babies.

In Vitro came from the Latin word which means:
�in glass and glass here referred to as the test tube. Therefore, in this process neither glass nor test tube is used, this term is generally used in laboratory procedures.

With the announcement of the birth of Louise Brown in 1978 through in vitro fertilization (IVF), the landscape of this field changed dramatically. On July 25, 1978, this was the moment in the life of Patrick Steptoe because on this day he delivered Louise Brown, conceived in the laboratory popularly known as the world�s first test-tube baby[1].

ART services have increased at the rate of 5-10% annually over the past decade[2]. More than 70 million are suffering from infertility[3]. After the first birth in 1978, this technology expanded around the globe[4].

It is suitable for people who are suffering from infertility. IVF is recommended to women who have damaged, blocked or missing fallopian tubes. IVF is also recommended when a male has infertility disorders like less sperm count, no sperm count, low sperm count. Being the medical treatment, the most severe side effect could be Ovarian hyperstimulation syndrome[5]. As more than one embryo is put back in the uterus it can also cause multiple pregnancies[6]. Around 30% of the IVF result in multiple pregnancies according to the report.

Current Regulations Prevailing In India:

After the first scientifically born test-tube baby in 1986 in India, the IVF clinics emerged across the country without the supervisory, regulatory body and control of the government. As a result, to which the Indian Council of Medical Research (ICMR) developed draft National Guidelines for ART Clinics in India in 2002. After considering these guidelines and a slight modification, the ministry of health and family welfare published the national guidelines of the government of India in 2005.

Later in 2008, the Indian council of medical research developed a draft for the ART regulation bill and was sent to the ministry of health and family welfare and was revised by the ministry of law and justice as an ART regulation bill 2013. The government had issued various guidelines which should be known to the physicians who are indulged in performing their work. Proper rules and regulations are still discussed in India. Therefore, in 2010 the Assisted Reproductive Technology Bill was drafted to govern the area of infertility treatment by covering some specific rules in egg donations, but this bill was failed to make it through parliament.

However, it drafted some guidelines for ART professionals. The ART industry was recognised as a 25000-crore gold pot according to the 228th Law Commission of India Report. Each state of India is recognised in its way to regulate IVF. However, in India, the Indian council of medical research is regulated for IVF[7]. Some guidelines are given to control In-vitro-fertilization by the Indian Council of Medical Research, such as the clinic, which should not reveal any sensitive donor and client details except in cases involving court order. The presented gamete should not be used by the clinic if the individual is under the age of 21. In India, the child born through the process of ART is to be considered as a legitimate child and shall be given all rights[8] as a natural biological child to protect the child from exploitation.

For instance, in the case named Doombos V. Doombos,[9] it was held on the wife�s petition for divorce and one of the issues before the court was the custody of the baby born of Assistance, approved by the husband: whether the boy is lawful and belongs only to the mother. The Court held that a child so conceived was not an unjustified, wedlock child. As such, it was the mother's child alone, and the husband had no rights or interest, not even visitation rights.

Therefore, the bill also made it mandatory to conduct tests so that they can identify the genetic defects in the embryos.

The Central Government approved the Assisted Reproductive Technology Regulation Bill 2020, to make a specific law relating to IVF. According to the bill, �NATIONAL BOARD�, will be an apex body made by the government which will regulate IVF clinics across the country. Moreover, this bill will act as a path-breaking bill for women in the country.

This board will formulate a code of conduct for the employees working at the clinics and will decide the standards of work and working environment which need to be maintained by the clinics. This bill also states that if a person found in the sale of embryos will be proved guilty under the human trafficking of human embryos and shall be fined 10 lakh rupees for the first time and could be imprisoned for 12 years for the second time. Hence, this eliminates the exploitation in the procedure of IVF.

Position Of IVF In India:

In-vitro Fertilization (IVF) has proven to be a boon offered to humans by humanity, a treatment that gives infertile couples the pleasure of being parents of their children. IVF services have become common in India over the millennium. The Indian IVF services industry will hit a CAGR of 16.6 per cent in 2022, at $775.9 million.

Fertility specialists also enjoy high demand, with the demand for IVF services, leading to further growth of their services. The demand for these facilities has been studied and the conditions that serve as catalysts for business development have been understood by fertility experts and researchers.

Some of the factors why the process of IVF is booming in India are as follow:
The rising number of infertile couples: The main reason for increasing the industry is infertility among married couples. About 10 to 14 per cent of the Indian population are affected by infertility according to statistics. Therefore, many other health issues led to infertility among married couples. IVF has played an important role and made a whole lot of difference for them which led to an increase in IVF services in India.

Changing lifestyle patterns: Today, with the changing lifestyle patterns girls think to start their families later in life due to this the age of marriage is postponed and, in the age of 20s, women are most fertile. Due to the delay, fertility gradually starts declining after the age of 32 and speeds up declining after the age of 35. This forms another reason that people are turning towards IVF services more often.

Cheaper health caregiving rises to medical tourism: IVF treatment is much less expensive as compared to the US and UK and the quality is also as good. Because of its cost-effectiveness in hospitals and health services, India has become a hub for medical tourism. This is an IVF services catalyst, as India is attracting more patients suffering from infertility from outside boarders. In India, IVF services are considerably cheaper but highly effective. Investors are also coming towards to invest in the IVF market, which appears to make a great profit from medical tourism.

Position Of IVF In Foreign Countries:

In foreign countries like the US, the treatment of infertile is not regarded as serious genuine medical care by many of the private insurance companies. Patients in the US are not allowed to claim treatment on private medical insurance as there is no federal medical cover available in IVF. As a result, infertility is not considered a disease. In the Clinton administration�s health security plan, 1993 IVF was excluded from the standard benefits package.

Thus, they are dependent much on the religion, social foundation, ethical, cultural beliefs of the area. Therefore, some states and countries still have a ban and restrictions on this medical procedure. This procedure is severely prohibited in Austria, Germany, France, and some US states whereas, in countries like Russia, Kazakhstan, South Africa is not banned. Countries like in Egypt and other Asian countries ART can only be conducted for married couples whereas, in France, Italy marriages or legal relationship are also necessary for IVF. Countries like Sweden, Denmark has no limitations or restrictions like this.

The world�s first test-tube baby was born in 1978 and the first child conceived through the in vitro procedure was in 1979 after 20 years of research by a British team in Great Britain [10]. In December 1981, the first IVF birth took place in the united states. More than 169 clinics have been established in the united states only since 1978.

In countries like Belgium, Israel, Italy, Holland, Denmark, Norway, Spain there is full state insurance provided for the people undergoing IVF or other ARTs.

The royal commission in Canada recommended that this IVF procedure is unethical and to devote public resources to them.

Therefore, there is a wide range between the cost and prices in different countries due to the different methods of calculations and because of the difference in wages, equipment, and prices among these countries. Moreover, many legislations or regulations have also been installed in different countries for the control of the undesired exploitation of the patient.

Ethical Issues With IVF:

Religion played an important role in the religious protestants, Catholics, Orthodox, and Muslim groups, and ART usage. For example, in the catholic church, adoption is acceptable but artificial insemination by husband or donor, or IVF is not allowed as they think that procreation with a sexual union is unnatural. In Judaism, insemination by donor is forbidden and a child considered as offspring of the biological father. To heal the illness of infertility, artificial insemination using the husband�s sperm or IVF are accepted.

In Germany, embryo research is banned. Therefore, many people believe that an embryo has the potential to be an individual or to become a human being and therefore it should not be should for research. Whereas other people think that reach on embryo is unfair to the people who are suffering from infertility and they should be allowed to make their own choices.

The technology of assisted technology will still have two views. At one end of the continuum, people would believe that this technology enables couples to exploit and object to nature. At the other end, people would assume that this invention is a victory over the naivety of individuals, who could be used to conquer the limitations of existence. These views - since these are founded on fundamental personal values (and not facts) - can never be reconciled, and we will have to learn to live with this moral dichotomy.

As to improve the chance of pregnancy many embryos are involved but only one can be used at a time due to this the embryos which are not needed are frozen for research work also the embryo which is frozen and are not transferred in the uterus are frozen for research or else destroyed. Many people believe that if an embryo is considered an individual then it is unethical to destroy it as it equivalent to intentionally killing an individual.

As an embryo is an individual and as an individual, an embryo should be recognised. From the very beginning of conception, an individual's life should be protected. However, others contend that embryos are too primitive for privileges and rights to be accorded. Thus, for study and elimination, it is ethical to use embryos that meet the needs of human beings. Discussions on embryo rights do not, unfortunately, respond to the question of whether embryo destruction is ethical.

IVF treatment treats an embryo by its essence as a product to buy and sell. Parents regard the child as an asset by IVF, as the offspring can be changed by IVF. We have no right to disrupt the natural process through artificial means to obtain the results.

Social Issues With IVF:

In India, women face social pressure to conceive soon after the marriage. The burden of infertility is primarily on the women even if the problem lies with the man. While facing the problem of infertility, she has to face severe psychological pressure, depression, social ostracization. To resolve this there are mainly two issues that need to be dealt with. Firstly, the medical knowledge to the patient as well as to the medical fraternity so that they can get the right treatment at the right time. Secondly, the social awareness to allow couples with dignity and privacy to face this issue.

In our country, the issue of social demoralization is very high, especially with women. Rather than having career achievements and academics, the value of women still lies in their capacity to bear a child. In many instances, women themselves are responsible for this situation. And these elderly women in the family rather than supporting the victims of infertility, physically and mentally they abuse them. There needs to be a multi-level approach right to the government from an individual. The main aim is to be empowering the women of India so that they can face the world with or without a child confidently.

Challenges And Risks With IVF:

The most important challenges of IVF are as follow:
Reprogenetics: As there is an increase in technology and the knowledge of scientific genomics it can give access to our personal genetic information. This will allow the people to edit the DNA of embryos according to them by considering reprogenetics along with IVF before transferring them into the uterus. It might help in preventing genetic disorder but can create discrimination and division in society.

Financial challenges: As IVF treatment is very costly. In India, the treatment of IVF is around 1.5 lakhs to 2.5 lakhs. Therefore, due to the cost of this treatment, it can be a limiting factor for many couples to wanted to opt for this treatment. This should include the insurance of the couple opting for this treatment as the success rate for this is 40%. but many insurance companies fail to give insurance for this treatment as insurance is for illness whereas treatment of fertility is not an illness.

Some suggestions for the challenges faced by people with IVF are as follow:
There should be proper insurance for this treatment as these treatments are costly. For people who opt for this treatment, there should be no financial burden on the couple. As success is only 30 to 40 % so paying out of pocket is not a viable option.

As science also considers the embryo as an individual therefore the state should ensure the proper way to use the frozen embryos and there should be a proper time limit for the use of frozen embryos.

When it comes to reprogenetics an intervention should be there to accept them legally as it is important for the society�s welfare and the future generation as it can create divide and division in the society.

There should be a proper ban on the trafficking and commercialization of embryos and guidelines should be made regarding this.

Approximately 10 per cent of people suffer from infertility and IVF is a treatment used to treat parents who cannot undergo parenthood. As, it is lawful and a helpful option, so clear legislation is necessary. The government should first adopt the Law on Assisted Reproductive Technology Bill. This bill will have a positive effect on women's freedom to reproduction and choice in India.

As we know, we cannot answer all these ethical, social, and legal problems concerning the adoption of IVF as they are socially different, but the bill can be considered a significant hallmark to resolve the question related to IVF. As a result, IVF treatment is increasing, creating a specific law for IVF will give a clear way to bloom in India. And instead of denouncing the women suffering from infertility, society should lend a helping hand so that the couples should get the right treatment at the right time. As infertility is mainly a curable disease.

  1. H. W. Jones, �Moments in the life of Patrick Steptoe,� Fertility and Sterility, vol. 66, no. 1, pp. 15�16, 1996
  2. G. M. Chambers, E. A. Sullivan, O. Ishihara, M. G. Chapman, and G. D. Adamson, �The economic impact of assisted reproductive technology: a review of selected developed countries,� Fertility and Sterility, vol. 91, no. 6, pp. 2281�2294, 2009.
  3. W. Ombelet, I. Cooke, S. Dyer, G. Serour, and P. Devroey, �Infertility and the provision of infertility medical services in developing countries,� Human Reproduction Update, vol. 14, no. 6, pp. 605�621, 2008.
  4. P. C. Steptoe and R. G. Edwards, �Birth after the reimplantation of a human embryo,� The Lancet, vol. 2, no. 8085, p. 366, 1978.
  6. W. L. Ledger, D. Anumba, N. Marlow, C. M. Thomas, and E. C. Wilson, �The costs to the NHS of multiple births after IVF treatment in the UK,� Journal of Obstetrics and Gynaecology, vol. 113, no. 1, pp. 21�25, 2006.
  7. Law commission of India
  8. Assisted Reproductive Technology (ART) Regulation Bill 2020
  9. (139, N.E.,2d 844 (1956)
  10. Johnson v. Calvert, 5 Cal. 4th 84, 105 (Cal. 1993).

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