Assisted Reproductive Technology (Regulation) Act, 2021 was passed on December 18, 2021, to regulate the activities related to alternate reproductive methods which help infertile married couples to conceive a child through Assisted Reproductive Technology. The method of reproduction under ART is carried out outside the human body by handling the sperm or the oocyte in clinics with all the requisite facilities and transferring the embryo into the reproductive system of a woman in an attempt to obtain pregnancy. The government, to smoothen the process, established a National Assisted Reproductive Technology and Surrogacy Board to look after the assisted reproductive technology clinics, responsible for performing activities related to assisted reproductive technology. The act was indispensable and the country was in the dire need of it as, before its implementation, there was no regulation in the processes like IVF (in vitro fertilisation), GIFT (gamete intrafallopian transfer), FET (frozen embryo transfer) and so on.
As per the private statistics of a survey conducted by the standing committee on Health and Family Welfare in 2017, around 2.8 crore couples in the reproductive age group in India are infertile. Under this category, 20-25% of people seek to undergo in vitro fertilisation. Keeping in mind a significant part of the population opting for these methods, the chances of corruption and malpractices were high in case of no regulation by the Government.
Provisions of the Act
The ART (Regulation) Act is mainly divided into VI chapters in which chapter III (section 15 to section 20) consisted of procedures and registrations of assisted reproductive technology clinics and ART banks. Chapter IV (section 21 to section 31) and chapter V (section 32 to section 37) deal with the duties of ART clinics and ART banks, and offences and penalties, respectively. section 21(g) of the said act talks about the age limit of the couples opting for ART by allowing the services given by ART clinics only to a woman between the age of twenty-one years to fifty years; and to a man between the age of twenty-one years to fifty-five years. The upper age limit prescribed in the act became a matter of dispute as it is considered irrational, arbitrary and violative of the right to reproduction, recognised as the right to personal liberty of a woman under Article 21 of the Indian constitution in the judgement of K.S. Puttaswamy v. Union of India. The Kerala High Court, in the case of XXXX v. Union of India and Ors., directed the National Assisted and Reproductive Technology and Surrogacy Board to include a transitional provision regarding the upper age limit within 3 months of the verdict.
Section 21(g) of the said act is unreasonable and strict in nature along with some other provisions. It is the personal choice of a person to build or expand a family and anything in contravention to the same, regardless of the age of the concerned person, would be considered a violation of his right to have a family as the individuals can build their family.
The ART (Regulation) Act, 2021 is stricter than the similar legislations of other countries like Australia, Canada, South Africa, and the United Kingdom as there is no upper age limit cap in their legislation to conceive a child through ART. Further, to avail of the services of ART clinics, marriage is essential in India but in the aforementioned countries, there is no requirement for marriage.
Changes Brought by ART (Regulation) Act
After the implementation of the ART (Regulation) Act, several regulation and changes has been imposed in the ART methods. The said act directs the provision of insurance coverage to the oocyte donor. An oocyte is a cell in the ovary which may undergo division to form a mature reproductive cell, responsible to give rise to an embryo after fertilisation of a male cell. Further, it says, a married woman having a living three-year-old child of her own shall be eligible to donate oocyte once in her lifetime.
The act also directs to provide of professional counselling to the commissioning couples about the ART process and its implications, advantages and disadvantages regarding financial burden, medical side-effects and risks along with the possibility of adoption among other things which would help the couple in the best possible way.
Possible Risks Associated with ART
With the greater benefits of ART, come a few drawbacks as well. First of all, it is an artificial process through which the couples managed to get a child. The process of ART is quite long and difficult and comes with mental, physical and financial stress to the couple without the guarantee to conceive a child successfully. The couple has to be of utmost caution while going through alternate reproductive methods, taking into consideration the risks of ovarian hyperstimulation, ovarian torsion, infection, bleeding, and multiple gestations, to name a few. These are the potential risks caused while going through the ART process. In case of an unsuccessful attempt, the couple has to go through the same process, if in any case, they still wish to have a child.
One of the frequent and serious risks of ART is multiple gestations. The Centres for Disease Control noted in a survey that ART is 27 times more likely to have twins than those who conceive naturally. The main reasons for the same are the transfer of multiple embryos in a woman’s body and the usage of ‘exogenous gonadotropins’ for controlled ovarian hyperstimulation.
The implementation of the ART (Regulation) Act was necessary for the country due to the expansion of this technology and its popularity among people at large. The regulation of the activities carried out by ART proved to be successful to a large extent and helpful in avoiding malicious acts which cannot be controlled in the absence of this act. The inclusion of some strict and unreasonable provisions questioned the constitutionality of the act in various instances but survived to maintain its validity each time. The Courts did pass some interim orders which were not in tune with the act before its enforcement but after the implementation of the act, while observing section 21(g) of ART (Regulation) Act, arbitrary to the personal liberty of a woman, given 3 months to reconsider the provisions of the section.
By looking at the risks and disadvantages a couple can suffer, it can be said that the ART process is at slightly extended risk compared to the natural pregnancy and a couple should indulge in it after comparing all the advantages, disadvantages and alternate ways to conceive a child.
Author(s) Name: Tushar Choubey (Faculty of Law, Jagran Lakecity University, Bhopal)