Abstract
The Assisted Reproductive Technology ( Regulation ) Act 2021 was introduced in Lok sabha on 14th september 2020 . After a thorough analysis the standing committee released its report on 19th march 2021 . The act was then passed during the winter session on 1st december 2021 by the minister of health and family welfare , Mansukh Mandavaiya. It lays down guidelines to be followed while availing assisted reproductive technologies . National and State Assisted Reproductive Technology and Surrogacy Board have been established under this act to make sure that they follow proper procedure and code of conduct.
Keywords
Assisted Reproductive Technology , ART , Surrogacy , Infertility
Introduction
“ There may be no families in utopia , and none in paradise , but the planet we know best will probably always contain them” as said by Robert Bierstedt . The family as an institution is universal and primary . Thinkers from all over the globe have tried to define family as an institution. Some of the prominent ones are :
- M F Nimkoff – “ Family is a more or less durable association of husband and wife with or without children or of a man or woman alone , with children.”
- Elliot and Merrill – “ The biological social unit composed of husband , wife and children.”
Even though different thinkers had different interpretations , the building block of the institution remained the same i.e rearing of children . Maintenance and rearing of children is the basic function on which a family as an institution is separated from other institutions . Unfortunately not all couples can reproduce which leads to rifts in the social structure . Infertility in man or woman hampers reproduction. Infertility , as defined by The World Health Organization, is a disease of the male or female reproductive system defined by the failure to achieve a pregnancy after 12 months or more of regular unprotected sexual intercourse. This is where the use of assisted reproductive technology comes into play .
Assisted reproductive technology or ART involves all those procedures in which an egg or embryo is handled . In simple terms , assisted reproductive technology is a process in which eggs are removed from a woman’s body and fused with a man’s sperm to create embryos. The embryos are then inserted back into the woman’s body. Some types of assisted reproductive technology are : a] IVF : In vitro fertilization, also known as test tube baby in layman’s terms, is a process in which eggs are combined with sperm in vitro . After the fertilization , the embryo is placed inside the uterus of the woman. b] Intrafallopian transfer : This is the process in which the gametes are directly transferred to the fallopian tube . c] Frozen embryo transfer : It is a process in which one or more embryos are frozen and then transferred to the uterus in order to establish pregnancy. The ART act was passed in December 2021. The ART services must include the following :
- Donation of sperm or oocyte
- In vitro fertilization clinics
- Gestational surrogacy ( here child is carried by non biological mother or surrogate mother)
These services can be availed from either ART clinics that offer ART related treatment and procedures or ART banks which store and supply gametes.
LITERATURE REVIEW
This paper focuses on studying the predominant aspects of the Assisted Reproductive Technology ( regulation )Act . The passing of this act is a step taken in the right direction as since the dawn of IVF there was a dire need to regulate the functions of clinics and establish rights of women . A research paper published on the same talks about how this act was a need of the hour . The study states that “ ART treatment involves retrieval, manipulation, storage, and application of gametes, embryos, and gonadal tissues. Cryopreservation of the gametes and embryos is done in special situations in assisted reproduction. Due to the sensitive nature of the treatments offered in the ART clinics and the hardships faced by infertile couples, there was a dire need for legislation in this emerging field of assisted reproduction.” The paper is a comprehensive analysis of the impacts , strengths and problems of the bill. It concludes by highlighting how the bill will help in proper supervision and licensing of ART clinics and banks , bringing changes to the ethical and legal framework of the country.
Another research paper focused mostly on the discriminatory feature of the act and argued that gender, sexual orientation or marital status should not have any say in determining whether an individual can undergo assisted reproductive technology or not . It has taken a forthright stance while analyzing the act . It reads that the current framework of the act is unacceptable and calls for certain amendments . The author of the research paper concludes by saying that the act be made gender neutral by replacing the terms “infertile couple” and “women” with “couple or individual.”
METHODOLOGY
The research paper is based on descriptive analysis wherein the focus is more on explaining ‘what is ’ rather than ‘why it is’. Multiple secondary sources like newspaper articles , journals and law reports have been referred for a proper analysis of the topic. It is mainly focused on providing a comprehensive understanding of the ART act. The purpose of this study is to thoroughly explain the act and its implications in the lives of couples . The paper also uses a comparative approach to provide insights into different ART acts in various countries further strengthening the basis of the study.
BACKGROUND TO THE BILL
The introduction of the ART act was not a brisk decision. It was made after years of deliberate discussions and recommendations.
- In 2005 , the Indian Council of Medical Research [ICMR] issued guidelines for clinics providing ART services . The guidelines provide for registration of clinics offering ART services, permit single women and couples to access ART services, and allow ART banks to compensate donors. These guidelines also specify conditions for when surrogacy may be opted, and the compensation for surrogates. However these were only guidelines and no hard law was passed. In an August 2009 report , the law commission of India pointed out that the bill itself was insufficient and incomplete, adding one more reason to not pass the bill.
- Then again the topic of ART was brought into notice in 2015 when the Government released its notification prohibiting commissioning of surrogacy in India by foreigners or OCI or PIO card holders but NRI holding Indian citizens could still avail surrogacy.
- Then in July 2019 , the surrogacy bill was passed . The Bill provides for the registration of surrogacy clinics, it also lays down the eligibility criteria of the surrogates and the couples. It provides for the establishment of boards to advise the government on surrogacy policies. The Bill was passed by Lok Sabha in August 2019. In Rajya Sabha, the Bill was referred to a Select Committee of the House. This committee recommended that the assisted reproductive technology bill should be brought first so that all highly technical and medical aspects could be subsequently highlighted in the surrogacy bill. There were certain terms and medical aspects which could not be explained in their entirety in the surrogacy bill which led to introduction of the ART bill.
- The assisted reproductive technology bill , 2020 was introduced by the Lok Sabha in September 2021. It was referred to a standing committee on Health and Family welfare in October 2020. The bill was finally passed on December 1, 2021. Under the bill , ART will include all the techniques that attempt to obtain a pregnancy by handling the sperm or oocyte outside the human body and transferring the gamete or embryo inside the reproductive system of a woman . The act has 46 clauses and 6 chapters :
- Chapter I : Preliminary
- Chapter II : Authorities to regulate ART
- Chapter III : Procedure for registration
- Chapter IV: Duties of ART clinic and ART banks
- Chapter V : Offenses and penalties
- Chapter VI : Miscellaneous
OVERVIEW OF THE PROVISIONS
1] Authorities to regulate the act : There are three authorities to regulate this act namely ,
{a} National Assisted Reproductive Technology and Surrogacy Board :
(i) To advise the central government on policy matters.
(ii) To implement the acts , rules and regulations.
(iii) To lay down code of conduct for people working in the clinics and banks
{b} State Assisted Reproductive Technology and Surrogacy Board :
(i) To follow the plans and policies laid down by the national board .
(ii) To implement the act at state level .
{c}National ART and Surrogacy Registry and the appropriate ART and surrogacy registry
(i) it shall act as a central database in the country through which the details of all the clinics and banks of the country including nature and types of services provided by them, outcome of the services and other relevant information shall be obtained on regular basis
(ii) it shall assist the National Board in its functioning by providing the data generated from the central database of the Registry;
(iii) Research based on the above data
Along with authorities to regulate and ensure proper functioning of the act , it also mentions provisions with respect to other key aspects to answer all the concerns with respect to assisted reproductive technologies. Registration of ART clinics and banks was one such provision.It ensured that each ART clinic or bank is required to register with the National Assisted Reproductive Technology and Surrogacy Board. The clinics must comply with guidelines encompassing specialized manpower, physical infrastructure, and diagnostic facilities to secure registration. The validity of this registration is limited to five years but can be renewed thereafter. Eligibility criteria for couples and women seeking ART services stipulate that the woman should be between 21 to 50 years of age, and the man should be between 21 to 55 years of age. These services are exclusively available to married couples and women facing infertility issues.In addition to the eligibility criteria for couples, specific requirements for donors are outlined. Male donors providing semen should be between 21 to 55 years of age, while female donors contributing eggs should be between 23 to 35 years of age. A woman may donate eggs only once in her lifetime, with a maximum limit of seven eggs per retrieval. Furthermore, the female donor (oocyte woman) should be ever married, possess at least one living child of her own, and the child should be at least three years old. Some conditions for offering the services are that there should be a written consent amongst the commissioning party and the donors. The commissioning party should provide insurance coverage to the egg donor in case of theft , loss or damage . The clinics are prohibited from providing any sex selective service . Section 31 of the bill provides for the rights of children born through ART . The child born through ART is deemed to be the biological child of the commissioning couple . A donor will not have any parental rights over the child . This bill not only talks about the features of assisted reproductive technology but also lays down punishments for illicit practices like sex determination, sale of human embryos or gametes, or found running agencies, rackets and organizations for such practices in violation of the law.For first-time offenders, a penalty in the range of Rs. 5 lakhs to Rs. 10 lakhs may be imposed. Subsequent contraventions could result in imprisonment for a duration spanning eight to 12 years, along with a fine ranging from Rs. 10 lakhs to Rs. 20 lakhs. Any clinic or bank engaging in the advertising or provision of sex-selective Assisted Reproductive Technology (ART) may face imprisonment lasting from five to ten years, a fine ranging from Rs. 10 lakhs to Rs. 25 lakhs, or both.Offenses : Offenses under the bill include – [a] abandoning or exploiting children born through ART [b] selling , purchasing or trading of human embryo or gamete [c] transferring the human embryo to male or animal [d] using intermediates to obtain donors .
DIFFERENCE BETWEEN SURROGACY AND ART BILLS
Often the ART bill and Surrogacy bill are interchangeably used however their ambit of discussions vary from one another . It was seen that both surrogacy and assisted reproductive technology are interdependent on each other and both procedures are undertaken under the same clinic . Even though they are related , both the bills have different scope to deal with .Surrogacy refers to a form of third party reproductive practice in which intending parent(s) contract a surrogate mother to give birth to a child . The Surrogacy ( Regulation ) Bill was passed in lok sabha in August 2019. Some key aspects due to which both the bills are distinguished from one another are :
- On the basis of eligibility – Eligibility literally means suitability to be chosen. Both the bills have different criterias with respect to their eligibility. In the surrogacy bill , the woman should be 23 to 50 years old and the man 26 to 55 . However in the ART bill the age criteria for women is 21 to 50 and for men it is 21 to 55 .
- On the basis of infertility – Infertility in surrogacy bill is defined as inability to conceive after 5 years of unprotected sex whereas in ART bill the time period is of just 1 year.
- Involvement of third person : The surrogacy bill involves a third person i.e a woman as the surrogate mother however in ART services the commissioning couple themselves avail the services .
- Surrogacy is allowed to Indian married couples only however ART services can be availed by foreigners as well as single couples .
It was observed by the Health Ministry that the number of surrogacy clinics in India was around 1,000 which was far less as compared to the ART clinics ( estimated to be more than 40,000). So it was necessary to bring in an ART bill to regulate all these clinics and protect the health of individuals who underwent these procedures .
INTERNATIONAL PERSPECTIVES
To study any act in its entirety , it is necessary to consider the international perspectives of the same. Different countries have different interpretations of a particular topic ,best lessons and practices can be learned from the application of ART globally .
In the United Kingdoms ,the Human Fertilisation and Embryology Act passed in the year 1990 , is responsible for regulating the assisted reproduction technologies in the country. Here the regulations of the parental rights and the rights of the children are similar to that of India. This act includes both types of pregnancy , through IVF and surrogacy . Commercial surrogacy is illegal . In the United States , assisted reproductive technology acts change from state to state. In Australia , National Health and Medical Research Council (NHMRC) , regulates and lays down guidelines for the assisted reproductive technologies that can be availed by individuals . Similar to the USA , each Australian state state and territory has different guidelines and regulations governing ART however these aspects govern only certain aspects of assisted reproductive technology .
STRENGTHS AND WEAKNESSES OF THE BILL
Assisted Reproductive Technology (ART) stands at the forefront of modern medical advancements, offering hope to individuals and couples facing challenges in conceiving naturally. Some of the pros of the ART act are that the laws governing the act are comprehensive and thus provide a clear and concise understanding of the legislation. Assisted reproductive technologies are well regulated and some of the guidelines are also kept either in the regulations or the rules. Surrogacy has been dealt with in a different act making the focus limited to studying assisted reproductive technologies .Punishments are too stringent which means that any kind of misuse can be punishable . Owners of the clinics and banks are punished if anything goes wrong . They need to be extra cautious as they are held accountable by default .
ART has undoubtedly brought many imperative changes however it is also necessary to analyze the social , ethical and legal implications of the law. This act has been criticized for a number of reasons , some of them are that the third gender and the GBTQ+ community are not allowed to undergo the ART procedure . Lesbian individuals can go through the same however other genders are prohibited to do so . This can be seen as a violation of Article 14 of the constitution. Unmarried couples and single men are not allowed to undergo art . Thus this is being seen as an act that is discriminatory towards men. Additionally , both ART bill and surrogacy bill will set up multiple bodies for registration which will lead to duplication of work or lack of regulation. The ART services are very costly and thus remain out of reach of most of the citizens .An absolute majority of India’s population is situated in the middle class and lower class who are unable to avail these services. Thus the cost of the services should be effectively monitored . Right to procreation of Article 21 of the constitution would be violated if the citizens do not get the opportunity to avail these services .
METHOD AND CONCLUSION
There is a common conception that assisted reproductive technologies are fairly new models of society however this is far from true. Durga was India’s first and world’s second test tube baby born on October 3rd, 1978 . However Dr Subhas Chatterjee , who claimed the credit of this success could not provide any adequate documentation for the same. Thus India’s first scientifically documented test tube baby is claimed to be born in 1986 with the collaboration of ICMR and KEM hospital . A technology that began its implementation over 50 years ago had no proper guidelines or set rules to ensure its execution. The introduction of assisted reproductive technology act came as a step into the right direction. This act was highly required as the ART clinics and banks have been mushrooming everywhere . It tries to provide a clear understanding and analysis on all the sensitive issues like genetics , infertility , how management of people should take place and many more such aspects. During late 2000’s the medical tourism market of India saw a rise wherein there was no proper regulation or protection of legal , medical or social life of the involved individual which further paved the path to develop a regulatory act. Even with all its pros , the act still seems to be a double edged sword. The act is facing a lot of backlash due to its discriminatory aspect of accessibility . There is no provision for single male or LGBTQ+ members to access these services. Moreover the services are very costly and thus cannot be accessed by poor strata of our country . This directly reflects upon our social justice system . A country like India that is developing in all aspects must not inculcate any provisions that promote gender or financial discrimination. An act becomes effective only when its effectiveness can be measured by all the individuals . Bringing a cap on citizens who can undergo an ART service betrays the trust of the citizens .
Suggestions
The key complaint against the act lies in the fact that it violates article 14 and 15 of the Indian constitution which talks about equality before the law and discrimination on the basis of age , gender , caste respectively. There exists no strong basis on which LGBTQ+ community cannot avail these services . Doing away with this one provision will itself lower the criticism of the act. Along with this it is necessary to provide counseling to the couples and also to make them aware about the psychological and social problems of the donor treatments.
To conclude , assisted reproductive technology act presents the country with a mixed bag that consists of both favorable and unfavorable elements. Regardless of these unfavorable elements , one must not forget the significant step that it has taken towards helping individuals overcome infertility. As we move forward , it is imperative to weigh both the positives and negatives highlighted in the study to ensure a well informed decision making.
Name : Avanti Pande
College: Indian Law Society [ ILS ]
Works Cited
- “The Assisted Reproductive Technology (Regulation) Act, 2021 and the Surrogacy (Regulation) Act, 2021.” Indian Council of Medical Research, 2 February 2022, https://main.icmr.nic.in/content/assisted-reproductive-technology-regulation-act-2021-and-surrogacy-regulation-act-2021-0. Accessed 15 February 2024.
- Kashyap, Soumya, and Priyanka Tripathi. “Assisted Reproductive Technology (Regulation) Act 2021: Critique and Contestations.” 2023, Assisted Reproductive Technology (Regulation) Act 2021: Critique and Contestations.
- THE ASSISTED REPRODUCTIVE TECHNOLOGY (REGULATION) ACT, 2021 ______________ ARRANGEMENT OF SECTIONS ______________ CHAPTER I SE.” India Code, 18 December 2021, https://www.indiacode.nic.in/bitstream/123456789/17031/1/A2021-42%20.pdf. Accessed 15 February 2024.
- Sharma, Radhey S. “National Guidelines for Accreditation, Supervision & Regulation of ART Clinics in India.” Indian Council of Medical Research, https://main.icmr.nic.in/sites/default/files/art/ART_Pdf.pdf. Accessed 15 February 2024.
- Yadav, Arun Kumar, and Vishan Dev Jamwal. “The Assisted Reproductive Technology (Regulation) Act, 2021: A Step in the Right Direction.” 2022, https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10112746/.