A Critical Analysis of the Draft Assisted Reproductive Technologies (Regulation) Bill & Rules, 2014.

Picture Courtesy: https://www.fau.edu/newsdesk/images/news/sperm-sorting-technology.jpg

This article was written by Ridita Shome, a student of Christ University, Bangalore. 

India in the last 2 decades has seen a major boom in the foreign service sectors, being one of the most important outsourcing destinations of the world. Apart from being a major market for the information technology (IT) services, it also serves as a very important marketplace for medical tourism. Every year, the country witnesses number of people flocking here for medical services, be it plastic surgery or joint replacement treatments. Relative affordability along with loose legal restrictions has made India an ideal place for such endeavours. With time, the concept of assisted reproductive technology(ART) and surrogacy has gained popularity across the world- a technique through which couples or individuals who are not blessed with a child through the natural process can get the joy through artificial methods. Surrogates are those who carry the baby of another couple in their womb during the gestation period in exchange for money. In the last three decades, India has seen a proliferation of assisted reproductive technology clinics that are not only catering to the domestic demands for various reproductive treatments but also are attracting a large number of foreign clients. The Indian Council of Medical Research (ICMR) has estimated that there are approximately 3,000 clinics in India.[1] Since the conception of ART procedures and surrogacy, a lot of countries have enacted regulations and developed laws and guidelines to check unethical practices and unproliferated growth of such clinics. But India has been unsuccessful in bringing out a well drafted Act to regulate assisted reproductive procedures and surrogacy. Although these ART clinics offer a wide range of treatment procedure for the couples/individuals seeking children, surrogacy still remains the most popular form of the procedures, thus making India a huge market for transnational surrogacy. The factors that attract foreign couples seeking surrogacy to India are low costs, easy access to the otherwise highly regulated technologies and easy availability of surrogate mothers and gamete donors. An IVF cycle in the US costs around $20,000 (approximately Rs 9, 00,000) as opposed to $2,000 (approximately 90,000) in India, while in clinics in the UK,a cycle costs up to£ 3,500 (approximately 2, 80,000)[2]. Similarly, the approximate cost of surrogacy in India is Rs 10 lakh compared to Rs 25-35 lakh in the US and there have been cases of women ready to conceive for Rs 8-10 lakh for the entire contract.[3] It is very evident from the above figures that it is generally the socio-economically marginalized women who agree to be surrogates in return for money as this becomes an easy access to money for them. These women are generally in a position where they are prone to exploitation and objectification of their bodies for the sake of money and they might not even be compensated adequately for their labour. Therefore, a proper legislation with clearly defined substantive and procedural guidelines covering every aspect of ART is the need of the hour.

The government of India had officially legalized surrogacy in 2002 but failed to come up with any guidelines then.The first reference to ART in an official document appeared in the” Ethical Guidelines for Biomedical Research on Human Participants” published by the ICMR in 2000[4]. Subsequently in 2002, the ICMR and the MOHFW formulated draft guidelines on Accreditation, Supervision& Regulation of ART Clinics in India, which was later, released as a published document in 2005. However, since these guidelines did not have a legal binding and the rules and regulations were not mandatory, they were not strictly implemented, resulting in an absence of any form of regulation. Recently, ICMR and MOHFW have come up with the Draft Assisted Reproductive Technologies(Regulation) Bill& Rules, 2014.

The Draft Assisted Reproductive Technology (Regulation) Bill, 2014 has made provisions for the establishment of a National Advisory Board, the State Advisory Boards and the National Registry for the accreditation, regulation and supervision of the ART clinics and the ART banks. This Act aims at prevention of misuse of ART procedures including surrogacy and safe and ethical practices.  It thereby specifies the duties and obligations of the ART clinics and banks and also of the gamete donors, surrogate mothers and the couples/individuals seeking ART. This bill has made detailed provisions aboutresearch on human embryos, duties regarding Pre Implantation Genetic Diagnosis (PGD) and Sex Selection. Besides, it deals with sourcing, storage and handling of gametes and embryos, restrictions on sale of gametes, zygotes and embryos.

The Bill, which is meant to regulate the booming ART industry and address the ethical and social issues regarding the same, apart from incorporating and providing a legal binding to the guidelines framed by ICMR, fails to fulfill its purpose in several aspects and still carries on the drawbacks of the 2005 guidelines. When the title of the bill carries the term ‘regulation’, it is expected that the aim of the bill would be to regulate the ART industry and safeguard the interests of the different stakeholders, especially the surrogate mothers in this case. However, the various clauses of the bill seek to promote the interests of the private sector providers and comeS across as inadequate in protecting the health and well-being of women and children- the vulnerable section of the society. The bill, thus, brings about a capitalistic approach to the whole concept of ART rather than bringing a well-being approach to it. Some of the basic flaws with the bill that needs to be addressed are:

ART Banks: – Traditionally, the procedure in which ART clinics work is that every ART clinic has an in-house semen bank, which provides donor gametes to the clinic, incorporating all the services under one roof. However, section 52(1) of the 2014 bill provides for an ART bank, which would be registered as a separate entity under the Act. Section 52(2) provides that the ART bank would function independently of any ART clinic. Moreover, the ART banks can also advertise for gamete donors and surrogates under section 52(6) of the bill. These provisions in the Act are only not provided without giving any rationale but it also poses certain practical fallacies when it comes to the execution of these provisions. It is clearly evident that most of the ART banks currently are not equipped to carry out the tasks that are assigned to them. The process of oocyte retrieval that is assigned to these banks is completely different from the process of sperm donation. It is an invasive procedure requiring ovarian stimulation with hormones and must be conducted in a clinical setup under proper medical supervision.[5] The present Act has not set any particular standards to be met by the banks and there are no clear directions regarding mandatory equipment and personnel in the bank, thus making it ambiguous as how the process would be conducted. The bill fails to have any provision that would specify the minimum qualifications and background of the persons who are eligible to open and run a bank. Keeping in mind the significant duties that are assigned to the ART banks, the bill also does not provide for the inspection and monitoring of banks. This aspect of bill has both advantages and disadvantages, but the basic problem lies in the implementation of the same. Most ART clinics have their own banks currently and making provisions just for separate registration of the banks would not necessarily ensure that the bank would function independently thereafter. Therefore, proper protocols, regulatory mechanisms and accreditations are necessary in order to monitor the practice of the bank.

Oocyte retrieval: – Section 52(8) (a) of the bill provides that the oocyte donor shall be allowed to donate oocytes only once in her life and not more than seven oocytes shall be retrieved from the oocyte donor. Although the maximum number of oocytes that can be retrieved from donor has been reduced from 14(in the previous bill) to 7(in the current bill), receiving such a large number of eggs requires hyper stimulating the ovaries by injecting hormonal drugs, which often leads to serious medical complications for women.[6] The retrieval process itself is highly invasive and might cause serious bodily injury to the women undergoing it. Also, the success rate of these procedures are generally quite less, so the women in most cases has to go through the process a number of times, which again has a detrimental effect on her health. One welfare amendment of the previous bill that is evident in the current bill is that the maximum number of times a woman can donate oocyte has only been restricted to one in her lifetime. However, the provisions contradict themselves in section 52(9) which says that “The eggs from one donor can be shared between two recipients only, provided that at least seven oocytes are available for each recipient.”On one hand, when the maximum number of oocyte that can be retrieved  is restricted to seven, then how can the eggs from one donor be shared between two recipients with each receiving seven oocytes?. The flow of payment to the egg donor is very ambiguous in the bill. The clauses, which seem to be harmful to the oocyte donors’ health coupled with the complicated payment process, put them in a vulnerable position[7].

Rights of the surrogate: – The main reason for transnational surrogacy gaining such huge popularity in India is the easy availability of surrogate mothers at comparatively cheaper rates. Most of these women who are ready to be surrogate for other couples hail from lower socio-economic backgrounds who see this as an easy opportunity to get extra money to run their family. Coming from such backgrounds puts these women in a vulnerable state when it comes to their position in the contract. The couples and the clinics make use of their low bargaining power to make a contract which is beneficial only to one party- the couples. The surrogates generally have no say in these matters. The 2014 ART bill, whose purpose is mainly to regulate the commercialization of the ART clinics and protect the interests of the gamete donors and surrogates has failed in its endeavor in many aspects. One major fallacy that the bill suffers with regards to the rights of the surrogate is that the bill has provisions for screening of gamete donors and surrogates whereas there are no provisions that ensures the screening of the intended parents/ commissioning couple as well. It clearly seems unfair on the part of the government to have such a provision which is discriminatory towards women.

Another problem that the current bill faces is with regards to the contract that is made between the intended parents and surrogate mother. Section 60(1) says “The couple commissioning surrogacy through the use of assisted reproductive technology, and the surrogate, shall enter into a surrogacy agreement which shall be binding on the parties”. The bill does not mention any other details of the administration of contract between the two parties. Who makes the contract? Who decides what happens if the contract is breached? What is the role of the ART bank in this contract? These are some of the questions which are not adequately answered in the bill and thereby leaves room for arbitrariness in the making of the contract. Furthermore, section 60(3)(a) states “notwithstanding anything contained in sub-section (2) and subject to the surrogacy agreement, the surrogate may also receive monetary compensation from the commissioning couple, as the case may be, for agreeing to act as surrogate.” The fact that it is the right of the surrogate to receive monetary compensation for her act is not specified. Besides, who decides the amount of compensation and what happens if the surrogate is not compensated adequately after she has delivered the baby is nowhere to be found in the bill. Since, the main intent of the bill is to regulate the commercialization of the ART industry, this factor needs to be addressed in the bill itself so that there is no room for ambiguity.

A look into the current bill clearly states that the terms and conditions of the contract and also the monetary compensation has to be mutually decided by the commissioning couple and the surrogate. But, considering that the surrogate is from a poor socio-economic background, her say in deciding the amount remains questionable[8]. There might be cases when the couple does not take the responsibility of the child after it is born. In such cases, what happens to the baby and also to the surrogate should also be clearly mentioned in the contract. Although the present bill mentions that the surrogate should be reimbursed all her medical expenses during the time of her pregnancy and also be insured for the same, these are some of the basic fallacies that need to be addressed.

Welfare of the child:- Section 61(1) determines the legitimacy of the child born to a couple through the use of ART and section 62(1) speaks about the right of the child to obtain information about the donor or surrogate upon reaching the age of 18. However, it falls short in the measures that need to be taken to ensure the well being of the child. There need to be special measures in the bill so that the welfare of the child is maintained and that the parents intending a baby through ART are of appropriate age and capable enough to raise a child till he/she reaches adulthood.

Assisted Reproductive Technology is one of the best examples of the extent of technological advancements in the world today. It is surely a bane and a blessing for those unfortunate couples who cannot have a baby through the traditional process and wish to do so. But, like any other technological advancement, this also comes with its own set of problems and shortcomings which needs to be addressed for it to function smoothly. The need of the hour is a legislation that regulates the commercialization of this procedure and the misuse of this technology through the exploitation of the vulnerable section and ensure the wellbeing aspect of everyone. But, as is clearly evident, the current ART bill that is on the table throws up a wide range of issues-medical, social and ethical.When it comes to the regulatory mechanisms of the bill, it is obvious that the drafting still has to come to terms with the wide range of challenges that ART faces. Therefore, what is required right now is a legislation that simplifies the process, eliminates intermediaries, prohibits activities that may lead to exploitation and establishes practices that uphold the dignity of the couples/ individuals accessing ART[9]. These are the broad parameters on which the present bill is considerably inadequate.

[1]SAMA TEAM,”Assisted Reproductive Technologies:For whose Benefir?”, Economic and Political Weekly, Vol.44, No. 18(May 2-8, 2009), pp.25-31, JSTOR,web, 15 Feb 2016.

[2]IMRANAQADEER AND MARY E. JOHN, “The Business and Ethics of Surrogacy”, Economic and Political Weekly, Vol.44, No. 2( Jan 10-16, 2009), pp.10-12, JSTOR, web,19 Feb 2016.

[3]IMRANAQADEER AND MARY E. JOHN, “The Business and Ethics of Surrogacy”, Economic and Political Weekly, Vol.44, No. 2( Jan 10-16, 2009), pp.10-12, JSTOR, web, 19 Feb 2016.

[4]PANDE AMRITA, “Commercial Surrogacy in India: Manufacturing  Perfect Mother-Worker”, Signs, Vol. 35, No.4( Summer 2010), pp.969-992, JSTOR, 25 Feb 2016.

[5]CHANG  MINA, “Womb for Rent: India’s Commercial Surrogacy”, Harvard International Review, Vol. 31, No. 1 (SPRING 2009), pp. 11-12, JSTOR, 28 Feb 2016.

[6]SAMA TEAM,”Assisted Reproductive Technologies:For whose Benefir?”, Economic and Political Weekly, Vol.44, No. 18(May 2-8, 2009), pp.25-31, JSTOR,web, 15 Feb 2016.

[7]CHANG MINA, “Womb for Rent: India’s Commercial Surrogacy”, Harvard International Review, Vol .31, No. 1 (SPRING 2009), pp. 11-12, JSTOR, 28 Feb 2016.

[8]VORA KALINDI, “ Potential, Risk, and Return in Transnational Indian Gestational Surrogacy”, Current Anthropology, Vol.54, No. S7, Potentiality and Humanness: Revisiting the Anthopological Object in Contemporary Biomedicine (October 2013), pp. S97-S106, JSTOR, 1 Mar 2016.

[9]PANDE AMRITA, “Commercial Surrogacy in India: Manufacturing  Perfect Mother-Worker”, Signs, Vol.35, No.4( Summer 2010), pp.969-992, JSTOR, 25 Feb 2016.